Safety, Feasibility, and Potential Clinical Efficacy of 40âHz Invisible Spectral Flicker versus Placebo in Patients with Mild-to-Moderate Alzheimer's Disease: A Randomized, Placebo-Controlled, Double-Blinded, Pilot Study.
J Alzheimers Dis
; 92(2): 653-665, 2023.
Article
em En
| MEDLINE
| ID: mdl-36776073
ABSTRACT
BACKGROUND:
Recent studies suggested induction of 40âHz neural activity as a potential treatment for Alzheimer's disease (AD). However, prolonged exposure to flickering light raises adherence and safety concerns, encouraging investigation of tolerable light stimulation protocols.OBJECTIVE:
To investigate the safety, feasibility, and exploratory measures of efficacy.METHODS:
This two-stage randomized placebo-controlled double-blinded clinical trial, recruited first cognitive healthy participants (nâ=â3/2 active/placebo), and subsequently patients with mild-to-moderate AD (nâ=â5/6, active/placebo). Participants were randomized 11 to receive either active intervention with 40âHz Invisible Spectral Flicker (ISF) or placebo intervention with color and intensity matched non-flickering white light.RESULTS:
Few and mild adverse events were observed. Adherence was above 86.1% of intended treatment days, with participants remaining in front of the device for >51.3âmin (60 max) and directed gaze >34.9âmin. Secondary outcomes of cognition indicate a tendency towards improvement in the active group compared to placebo (mean -2.6/1.5, SD 6.58/6.53, active/placebo) at week 6. Changes in hippocampal and ventricular volume also showed no tendency of improvement in the active group at week 6 compared to placebo. At week 12, a potential delayed effect of the intervention was seen on the volume of the hippocampus in the active group compared to placebo (mean 0.34/-2.03, SD 3.26/1.18, active/placebo), and the ventricular volume active group (mean -0.36/2.50, SD 1.89/2.05, active/placebo), compared to placebo.CONCLUSION:
Treatment with 40âHz ISF offers no significant safety or adherence concerns. Potential impact on secondary outcomes must be tested in larger scale clinical trials.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fototerapia
/
Doença de Alzheimer
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Aged
/
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
J Alzheimers Dis
Assunto da revista:
GERIATRIA
/
NEUROLOGIA
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Dinamarca