Time trends in demographic characteristics of participants and outcome measures in Parkinson's disease research: A 19-year single-center experience.

Background: Females, people with young-onset PD and older individuals, and non-white populations are historically underrepresented in clinical Parkinson's disease (PD) research. Furthermore, research traditionally focused predominantly on motor symptoms of PD. Including a representative and diverse group of people with PD and also studying non-motor symptoms is warranted to better understand heterogeneity in PD and to generalize research findings. Objective: This project aimed to determine whether, within a consecutive series of PD studies performed within a single center in the Netherlands: (1) the proportion of included females, mean age and proportion of native Dutch people changed over time; and 2) reports of the ethnicity of participants and the proportion of studies with non-motor outcomes changed over time. Methods: Characteristics of participants and non-motor outcomes were analyzed using a unique dataset of summary statistics of studies with a large number of participants conducted at a single center during a 19-year period (2003-2021). Results: Results indicate no relationship between calendar time and proportion of females (mean 39 %), mean age (66 years), proportion of studies that reported ethnicity, and proportion of native Dutch people in studies (range 97-100 %). The proportion of participants in whom non-motor symptoms were assessed increased, but this difference was consistent with chance. Conclusion: Study participants in this center reflect the PD population in the Netherlands in terms of sex, but older individuals and non-native Dutch individuals are under-represented. We have still a lot to do in ensuring adequate representation and diversity in PD patients within our research.

Using former carers' expertise in peer support for carers of people with Parkinson's Disease.

Informal carers gain unique experience and knowledge when caring for a loved person. However, this knowledge often remains unused after their loved one with Parkinson's disease (PD) has passed away. Hence, two opportunities are currently being missed: sharing this unique experience could support current informal carers and offer the bereaved former carers the option to continue to fulfil a meaningful role. This study aimed to identify the unmet needs of current carers, and to examine the interest, willingness and requirements of both current and former carers for peer-to-peer support. Data were collected from August 2020 to February 2021 through questionnaires examining (1) resources and needs for support; (2) topics for support and advice; and (3) preferences for peer-to-peer initiatives. Open questions were analyzed thematically, after open coding. In total, 141 current and 15 former informal carers participated. Current carers were mainly women (68%) and partner of a person with PD (86%). Former carers were mainly women (80%) who had cared for a partner or parent (53%; 47%) with PD. Almost half of the current carers expressed need for additional support in finding balance, changing relationships, and learning how to cope with lack of emotions and motivation. Half of the carers were positive about the opportunity to exchange experiences and knowledge with former carers. Willingness among former carers for providing peer-to-peer support was high (87%). In both groups, having a degree of commonality with peers was considered an essential requirement. These findings provide guidance for developing peer-to-peer support programs, incorporating former carers.

Communication between Dutch community nurses and general practitioners lacks structure: An explorative mixed methods study .

BACKGROUND: Community nurses and general practitioners evaluate their patient-related communication to be poor. However, their actual communication has hardly been investigated and specific strategies for improvement are unclear. OBJECTIVES: To explore actual community nurse-general practitioner communication in primary care and gain insights into communication style, and conversation structure and their determinants. METHODS: A mixed-methods design was applied. Telephone conversations between community nurses and general practitioners in the Netherlands were recorded and transcribed verbatim. We measured structure and the duration of their conversations, and community nurses' self-confidence towards general practitioners and their trust in and familiarity with the conversation partner. A thematic analysis was applied to the transcripts of the conversations. Correlations between these determinants were calculated using Spearman's correlation coefficient. RESULTS: The 18 community nurses recorded 23 conversations with general practitioners. Qualitative analysis revealed that many conversations lacked structure and conciseness, i.e. the nurses started conversations without a clearly articulated question and did not provide adequate background information. The mean duration of their conversations with doctors was 8.8 min. Community nurses with higher self-confidence towards doctors communicated in a more structured way (p = 0.01) and general practitioners were more satisfied about the conversations (p = 0.01). CONCLUSION: This exploratory study of actual community nurse-doctor telephone conversations in primary care identified communication structure and nurse self-confidence towards general practitioners as key targets for the improvement of interprofessional communication, which may increase the effectiveness of community nurse-general practitioner collaboration.

Geriatric models of care for neurodegenerative disorders.

New models of care seek to reorganize healthcare to meet the challenges of a growing number of persons with chronic conditions, to optimize the use of the available workforce, and to improve the quality of care. Increasingly, these models also seek to organize care in a manner that addresses cost and efficiency in addition to quality of care. This chapter first revisits the history of chronic care models and then provides a description of successful and sustainable examples of integrated, multidisciplinary approaches for persons with dementia, persons with Parkinson's disease, and the frail elderly. We focus on models for neurodegenerative diseases and draw from the perspectives of research, clinical practice, and informal caregiving. Although focused on neurodegenerative disease, the principles of these approaches reflect the hallmarks of good primary, geriatric, and collaborative care. Many of the current models of care emanate from a medical approach led by physicians and other professional providers within the formal healthcare setting. Innovative approaches, however, now seek to incorporate these medical models within social and community services. We conclude this chapter by describing several international examples of community-based efforts that have been implemented to improve the care and lives of patients with dementia and their informal caregivers, which is at present one of the top priorities in many countries.

Clinical leadership and integrated primary care: A systematic literature review.

BACKGROUND: Leaders are needed to address healthcare changes essential for implementation of integrated primary care. What kind of leadership this needs, which professionals should fulfil this role and how these leaders can be supported remains unclear. OBJECTIVES: To review the literature on the effectiveness of programmes to support leadership, the relationship between clinical leadership and integrated primary care, and important leadership skills for integrated primary care practice. METHODS: We systematically searched PubMed, CINAHL, Embase, PsycINFO until June 2018 for empirical studies situated in an integrated primarycare setting, regarding clinical leadership, leadership skills, support programmes and integrated-care models. Two researchers independently selected relevant studies and critically appraised studies on methodological quality, summarized data and mapped qualitative data on leadership skills. RESULTS: Of the 3207 articles identified, 56 were selected based on abstract and title, from which 20 met the inclusion criteria. Selected papers were of mediocre quality. Two non-controlled studies suggested that leadership support programmes helped prepare and guide leaders and positively contributed to implementation of integrated primary care. There was little support that leaders positively influence implementation of integrated care. Leaders' relational and organizational skills as well as process-management and change-management skills were considered important to improve care integration. Physicians seemed to be the most adequate leaders. CONCLUSION: Good quality research on clinical leadership in integrated primary care is scarce. More profound knowledge is needed about leadership skills, required for integrated-care implementation, and leadership support aimed at developing these skills.

Longitudinal multiple case study on effectiveness of network-based dementia care towards more integration, quality of care, and collaboration in primary care.

INTRODUCTION: This study aimed to provide insight into the merits of DementiaNet, a network-based primary care innovation for community-dwelling dementia patients. METHODS: Longitudinal mixed methods multiple case study including 13 networks of primary care professionals as cases. Data collection comprised continuously-kept logs; yearly network maturity score (range 0-24), yearly quality of care assessment (quality indicators, 0-100), and in-depth interviews. RESULTS: Networks consisted of median nine professionals (range 5-22) covering medical, care and welfare disciplines. Their follow-up was 1-2 years. Average yearly increase was 2.03 (95%-CI:1.20-2.96) on network maturity and 8.45 (95%-CI:2.80-14.69) on quality indicator score. High primary care practice involvement and strong leadership proved essential in the transition towards more mature networks with better quality of care. DISCUSSION: Progress towards more mature networks favored quality of care improvements. DementiaNet appeared to be effective to realize transition towards network-based care, enhance multidisciplinary collaboration, and improve quality of dementia care.

Identification of influencing factors and strategies to improve communication between general practitioners and community nurses: a qualitative focus group study.

Background: As the number of patients with complex healthcare needs grows, inter-professional collaboration between primary care professionals must be constantly optimized. General practitioners (GPs) and community nurses (CNs) are key professions in primary care; however, poor GP-CN communication is common, and research into the factors influencing its quality is limited. Objective: To explore patient-related GP-CN communication and facilitating and hindering factors, and to identify strategies to enhance this communication. Method: A qualitative focus group design was used to identify the facilitating and hindering factors and strategies for improvement. In a Dutch primary care setting, 6 mono-professional focus group interviews (3 meetings of 13 GPs; 3 meetings of 18 CNs) were organized between June 2015 and April 2016, recorded and transcribed verbatim. Two independent researchers performed the coding of these interviews, identifying their categories and themes. Results: Results show that, despite the regular contact between GPs and CNs, communication was generally perceived as poor in effectiveness and efficiency by both professions. Mutual trust was considered the most important facilitating factor for effective communication. Profession-specific factors (e.g. differences in responsibility and profession-specific language) and organizational factors (e.g. lack of shared care plans, no in-person communication, lack of time) may be of influence on communication. Participants' suggestions for improvement included organizing well-structured and reimbursed team meetings and facilitating face-to-face contact. Conclusion: GP-CN patient-related communication benefits most from trusting inter-personal relationships. Inter-professional training programmes should address both professional and organizational factors and should be evaluated for their effect on quality of care.

[Guideline on medical research in older persons]. / Leidraad voor medisch wetenschappelijk onderzoek bij ouderen.

This paper describes the development of a guideline on medical research with older subjects. Although our society is aging, evidence on health care for older persons is lacking on many topics, because these subjects are underrepresented in most drug and non-drug trials, while these services are used many older persons, and result in many adverse reactions and unplanned hospitalisation. Part of the reasons for this underrepresentation is the multimorbidity, often leading to exclusion, but also the lack of appropriate research methods plays a major role. Therefore, this paper describes the methods and results of the development of a multidisciplinary, evidence based guideline on how to conduct medical research in older persons. The recent changes in European and Dutch legislation on medical research were another reason to start this guideline project. We conducted two systematic reviews (on informed consent and recruitment) and conducted surveys and focus groups on the other four topics covered by the paper: proportionality, resistance, drop out, and societal relevance. In total we formulated 45 recommendations, all agreed on in consensus meetings, in which older persons' representatives played a major role. This Guideline on medical research in older persons, will be implemented via the ethical review boards, the medical scientific committees, and the Ministry of Health in the Netherlands, who commissioned the guideline work. We hope the guideline stimulates quality and quantity of research on older adults to answer the increasing number of societal and scientific questions with regard to this populations.

Evaluation of DementiaNet, a network-based primary care innovation for community-dwelling patients with dementia: protocol for a longitudinal mixed methods multiple case study.

INTRODUCTION: Primary healthcare professionals will increasingly be required to manage and optimise their treatment for patients with dementia. With DementiaNet, we aim to reduce the burden of dementia on healthcare services and society through implementation and facilitation of integrated network-based care with increased dementia expertise. DementiaNet is designed as a stepwise approach including clinical leadership, quality improvement cycles and interprofessional training, which are tailor-made to the local context. For example, the composition of the network and improvement goals are tailored to the local context and availability. Here, we describe the linked evaluation study which aims to provide insight in effectiveness, process and mechanism of the DementiaNet approach through an innovative evaluation design. METHODS AND ANALYSIS: We designed a longitudinal, mixed methods, multiple case study. Study population consists of two levels: (i) local DementiaNet networks of primary care professionals and (ii) patients and informal caregivers who receive care from these networks. At the start and after 12 and 24 months, quantitative data are collected for each network on: level of network maturity, quality of care indicators and outcomes reported by informal caregivers of dementia patients. We assess changes in networks over time and the association with quality of care and informal caregiver-reported outcomes. Throughout the study, logs about each network are registered. Additionally, semi-structured interviews with network members and informal caregivers will provide insight in experiences and opinions regarding effects and mechanisms through which changes in quantitative outcomes are effectuated. Rich narratives will be constructed about the development of the local networks using collected data. ETHICS AND DISSEMINATION: The study protocol was reviewed by the local medical ethics committee; formal judgement was not required (protocol number: 2015-2053). The findings of this study will be disseminated through peer-reviewed publications, conference presentations and presentations for healthcare professionals where appropriate.

Perseverance time of informal caregivers for people with dementia: construct validity, responsiveness and predictive validity.

BACKGROUND: Informal care is essential for many people with dementia (PwD), but it often results in a considerable burden for the caregiver. The perseverance time instrument integrates the aspect of perceived burden with the caregiver's capacity to cope with the burden, in contrast to most available instruments, which measure solely the burden of caregiving. The aim of this study was to extend insight into psychometric properties of the perseverance time instrument, specifically the construct validity, responsiveness, and predictive validity, within the population of informal caregivers for PwD. METHODS: Data from two studies among informal caregivers of community-dwelling PwD in the Netherlands were used. The first study included 198 caregivers from a single region in the Netherlands and lasted 1 year. The second was a cross-sectional nationwide study with 166 caregivers for PwD. Questionnaires of both studies included questions regarding demographics and informal care, perseverance time, and other informal caregiver outcomes (Caregiver Strain Index, Self-rated Burden scale, Care-related Quality of Life instrument, and visual analogue scale health scores). Construct validity and responsiveness were assessed using a hypothesis-testing approach. The predictive validity of demographic characteristics and perseverance time for living situation after 1 year (living at home, institutionalized, or deceased) was assessed with multivariable multinomial regression. RESULTS: All but one of the hypotheses regarding construct validity were met. Three of five hypotheses regarding responsiveness were met. Perseverance time scores at baseline were associated with living situation after 1 year (p < 0.01), unlike age, sex, and relationship with PwD. Perseverance time strongly increased predictive power for living situation after 1 year (c-index between 0.671 and 0.775) in addition to demographic characteristics. CONCLUSIONS: This study supports previous findings regarding the construct validity of the perseverance time instrument and adds new evidence of good construct validity, responsiveness, and predictive validity. The predictive power of perseverance time scores for living situation exceeds the predictive power of other burden measures and indicates informal care as an important factor for maintaining the patient at home.

Dementia care management in primary care : Current collaborative care models and the case for interprofessional education.

BACKGROUND: Dementia is one of the most prevalent diseases in the older population. Various dementia care models have been developed to address patient's healthcare needs. They can be described as "collaborative care" or "person-centered care". Referring to the needs of the workforce working with persons with dementia, a key element is the use of interprofessional education (IPE). OBJECTIVE: The purpose of this article is to describe different international collaborative care models to define a minimum standard of healthcare professions for collaborative dementia care in primary care. This helps to identify requirements for IPE to optimize care of people with dementia and to support informal caregivers in the future. MATERIAL AND METHODS: In this article six dementia care models from 4 different countries (Germany, USA, UK and Netherlands) are described and compared regarding aims, interventions and healthcare professionals involved. RESULTS: Care teams are minimally comprised of general practitioners or primary care providers, nurses, and social workers. Additional healthcare disciplines may be involved for specific interventions. Mostly, care team members received specific training but such training did not necessarily incorporate the IPE approach. To ensure successful collaboration of professions, IPE training programs should at least consist of the following core topics: (1) early diagnosis, (2) postdiagnostic support, (3) advanced care planning for patients and caregivers and (4) effective collaborative care. CONCLUSION: The IPE programs for dementia should be expanded and must be widely implemented in order to assess the impact on collaborative practice. This study will provide the knowledge base for structuring IPE trainings developing educational agendas and adapting existing guidelines to improve collaborative dementia care in the future.

Effects of tetrahydrocannabinol on balance and gait in patients with dementia: A randomised controlled crossover trial.

Oral tetrahydrocannabinol (THC) is currently studied for its possible efficacy on dementia-related neuropsychiatric symptoms (NPS), but might lead to increased risk of falling. This was a randomised, double-blind, crossover study to evaluate the effects of THC on mobility in dementia patients. Eighteen community-dwelling patients ( Mage=77 years) received 1.5 mg of oral THC twice daily and placebo, in random order, for three days, separated by a four-day washout. Balance and gait were assessed using SwayStarTM and GAITRiteTM within two hours after administration, in two consecutive intervention periods, under the following conditions: standing with eyes open (EO) and eyes closed (EC), preferred speed walking with and without a cognitive dual task. THC significantly increased sway during standing EC (roll angle 0.32[±0.6]°, p=0.05; pitch angle 1.04[±1.5]°, p=0.009; pitch velocity 1.96[±3.3]°/s, p=0.02), but not during standing EO. During preferred speed walking, THC increased stride length (4.3[±5.4] cm, p=0.005) and trunk sway (pitch angle 1.18[±1.6]°, p=0.005). No effects were observed during dual task walking. No differences in the number and type of adverse events were found, and no falls occurred after administration of THC. This study showed that 3 mg of THC per day has a benign adverse event profile regarding mobility and was well tolerated by community-dwelling dementia patients.

The International Dementia Alliance Instrument for Feasible and Valid Staging of Individuals with Dementia by Informal Caregivers.

OBJECTIVES: To assess the feasibility and validity of the International Dementia Alliance (IDEAL) instrument for Informal Caregivers (IDEAL-IC), which is based on the IDEAL instrument for professionals (IDEAL-P), for staging individuals with dementia. DESIGN: Cross-sectional. SETTING: Memory clinic of a university hospital. PARTICIPANTS: Informal caregivers of 73 community-dwelling elderly adults referred to a memory clinic and six geriatric registrars. MEASUREMENTS: Caregivers completed the IDEAL-IC; physicians completed the original IDEAL-P and the Clinical Dementia Rating sum of boxes (CDR-SB). Missing items and floor and ceiling effects were reviewed to assess feasibility. To test construct validity, a priori hypotheses were defined for expected correlations between IDEAL-IC, IDEAL-P, and CDR-SB scores. RESULTS: Seventy-three IDEAL-IC instruments were completed, 86% of which had no missing items. Three percent of all 730 individual items were missing. No floor or ceiling effects were detected. CDR scores were 0 7%, 0.5 in 33%, 1 in 27%, 2 in 10%, and unknown in 23%. IDEAL-IC scores correlated highly with IDEAL-P scores (correlation coefficient (r) = 0.70) and with CDR-SB scores (r = 0.65) as expected; the difference between these two correlations was smaller than expected. Agreement between IDEAL-IC and IDEAL-P scores was 34% within a range of 1 point difference on 36-point scales, 57% within a range of two points, and 81% within a range of five points. Correlation between IDEAL-P and CDR-SB was very high (r = 0.85). CONCLUSION: Results of this study indicate good feasibility and high validity of staging dementia by informal caregivers using the IDEAL-IC.

Tetrahydrocannabinol in Behavioral Disturbances in Dementia: A Crossover Randomized Controlled Trial.

OBJECTIVES: Neuropsychiatric symptoms (NPS) are highly prevalent in dementia, but effective pharmacotherapy without important side effects is lacking. This study aims to assess the efficacy and safety of oral tetrahydrocannabinol (THC) in the treatment of NPS in dementia. DESIGN: Randomized, double-blind, placebo-controlled, repeated crossover trial, consisting of six treatment blocks of 2 weeks each. SETTING: Two hospital sites in The Netherlands, September 2011 to December 2013. PARTICIPANTS: Patients with dementia and clinically relevant NPS. INTERVENTION: Within each block THC (0.75 mg twice daily in blocks 1-3 and 1.5 mg twice daily in blocks 4-6) and placebo were administered in random order for 3 consecutive days, followed by a 4-day washout. MEASUREMENTS: Primary outcome was change in Neuropsychiatric Inventory (NPI) score. Analyses were performed intention-to-treat. Data from all subjects were used without imputation. Sample size required for a power of 80% was 20 patients, because of repeated crossover. RESULTS: 22 patients (15 men, mean age 76.4 [5.3] years) were included, of whom 20 (91%) completed the trial. THC did not reduce NPI compared to placebo (blocks 1-3: 1.8, 97.5% CI: -2.1 to 5.8; blocks 4-6: -2.8, 97.5% CI: -7.4 to 1.8). THC was well tolerated, as assessed by adverse event monitoring, vital signs, and mobility. The incidence of adverse events was similar between treatment groups. Four non-related serious adverse events occurred. CONCLUSIONS: This is the largest randomized controlled trial studying the efficacy of THC for NPS, to date. Oral THC did not reduce NPS in dementia, but was well tolerated by these vulnerable patients, supporting future higher dosing studies.

[Broadening of opportunities for research with older persons: adaptation of the Medical Research Involving Human Subjects Act]. / Ruimere mogelijkheden voor onderzoek met ouderen: aanpassing Wet Medisch-wetenschappelijk Onderzoek met Mensen.

Older persons represent a growing proportion of the population. However, few of them participate in medical research. Moreover, amendments have been proposed to the Medical Research Involving Human Subjects Act (WMO) concerning the participation of vulnerable subjects such as older persons. In light of these changes, the Dutch Ministry of Health, Welfare and Sport sought to develop a guideline to improve the quality of research involving older persons. This guideline will also be a tool for researchers to enhance the inclusion of older persons in their medical research. It focuses on six aspects to consider when setting up a research project: recruitment, informed consent, attrition, reluctance to participate, proportionality between the burden for participants and the benefits for the investigator, and societal relevance.

Tetrahydrocannabinol for neuropsychiatric symptoms in dementia: A randomized controlled trial.

OBJECTIVE: To study the efficacy and safety of low-dose oral tetrahydrocannabinol (THC) in the treatment of dementia-related neuropsychiatric symptoms (NPS). METHODS: This is a randomized, double-blind, placebo-controlled study. Patients with dementia and clinically relevant NPS were randomly assigned to receive THC 1.5 mg or matched placebo (1:1) 3 times daily for 3 weeks. Primary outcome was change in Neuropsychiatric Inventory (NPI), assessed at baseline and after 14 and 21 days. Analyses were based on intention-to-treat. RESULTS: Twenty-four patients received THC and 26 received placebo. NPS were reduced during both treatment conditions. The difference in reduction from baseline between THC and placebo was not significant (mean difference NPItotal: 3.2, 95% confidence interval [CI] -3.6 to 10.0), nor were changes in scores for agitation (Cohen-Mansfield Agitation Inventory 4.6, 95% CI -3.0 to 12.2), quality of life (Quality of Life-Alzheimer's Disease -0.5, 95% CI -2.6 to 1.6), or activities of daily living (Barthel Index 0.6, 95% CI -0.8 to 1.9). The number of patients experiencing mild or moderate adverse events was similar (THC, n = 16; placebo, n = 14, p = 0.36). No effects on vital signs, weight, or episodic memory were observed. CONCLUSIONS: Oral THC of 4.5 mg daily showed no benefit in NPS, but was well-tolerated, which adds valuable knowledge to the scarce evidence on THC in dementia. The benign adverse event profile of this dosage allows study of whether higher doses are efficacious and equally well-tolerated. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with dementia-related NPS, low-dose THC does not significantly reduce NPS at 21 days, though it is well-tolerated.

Safety, pharmacodynamics, and pharmacokinetics of multiple oral doses of delta-9-tetrahydrocannabinol in older persons with dementia.

RATIONALE: Data on safety, pharmacodynamics, and pharmacokinetics of tetrahydrocannabinol (THC) are lacking in dementia patients. METHODS: In this randomized, double-blind, placebo-controlled, crossover trial, we evaluated the safety, pharmacodynamics, and pharmacokinetics of THC in ten patients with dementia (mean age 77.3 ± 5.6). For 12 weeks, participants randomly received oral THC (weeks 1-6, 0.75 mg; weeks 7-12, 1.5 mg) or placebo twice daily for 3 days, separated by a 4-day washout period. RESULTS: Only 6 of the 98 reported adverse events were related to THC. Visual analog scale (VAS) feeling high, VAS external perception, body sway-eyes-open, and diastolic blood pressure were not significantly different with THC. After the 0.75-mg dose, VAS internal perception (0.025 units; 95% CI 0.010-0.040) and heart rate (2 beats/min; 95% CI 0.4-3.8) increased significantly. Body sway-eyes-closed increased only after 1.5 mg (0.59°/s; 95% CI 0.13-1.06). Systolic blood pressure changed significantly after both doses of THC (0.75 mg, -7 mmHg, 95% CI -11.4, -3.0; 1.5 mg, 5 mmHg, 95% CI 1.0-9.2). The median T max was 1-2 h, with THC pharmacokinetics increasing linearly with increasing dose, with wide interindividual variability (CV% up to 140%). The mean C max (ng/mL) after the first dose (0-6 h) was 0.41 (0.18-0.90) for the 0.75-mg dose and 1.01 (0.53-1.92) for the 1.5-mg dose. After the second dose (6-24 h), the C max was 0.50 (0.27-0.92) and 0.98 (0.46-2.06), respectively. CONCLUSIONS: THC was rapidly absorbed and had dose-linear pharmacokinetics with considerable interindividual variation. Pharmacodynamic effects, including adverse events, were minor. Further studies are warranted to evaluate the pharmacodynamics and efficacy of higher THC doses in older persons with dementia.

Safety and pharmacokinetics of oral delta-9-tetrahydrocannabinol in healthy older subjects: a randomized controlled trial.

There is a great concern about the safety of THC-based drugs in older people (≥65 years), as most of THC-trials did not include such group. In this phase 1, randomized, double-blind, double-dummy, placebo-controlled, cross-over trial, we evaluated the safety and pharmacokinetics of three oral doses of Namisol(®), a novel THC in tablet form, in older subjects. Twelve healthy older subjects (6 male; mean age 72±5 years) randomly received a single oral dose of 3mg, 5mg, or 6.5mg of THC or matching placebo, in a crossover manner, on each intervention day. The data for 11 subjects were included in the analysis. The data of 1 subject were excluded due to non-compliance to study medication. THC was safe and well tolerated. The most frequently reported adverse events (AEs) were drowsiness (27%) and dry mouth (11%). Subjects reported more AEs with THC 6.5mg than with 3mg (p=0.048), 5mg (p=0.034) and placebo (p=0.013). There was a wide inter-individual variability in plasma concentrations of THC. Subjects for whom the Cmax fell within the sampling period (over 2h), Cmax was 1.42-4.57ng/mL and Tmax was 67-92min. The AUC0-2h (n=11) was 1.67-3.51ng/mL. Overall, the pharmacodynamic effects of THC were smaller than effects previously reported in young adults. In conclusion, THC appeared to be safe and well tolerated by healthy older individuals. Data on safety and effectiveness of THC in frail older persons are urgently required, as this population could benefit from the therapeutic applications of THC.