Evaluating the Use of Digital Biomarkers to Test Treatment Effects on Cognition and Movement in Patients with Lewy Body Dementia.
J Parkinsons Dis
; 12(6): 1991-2004, 2022.
Article
en En
| MEDLINE
| ID: mdl-35694933
ABSTRACT
BACKGROUND:
PRESENCE was a Phase 2 trial assessing mevidalen for symptomatic treatment of Lewy body dementia (LBD). Participants received daily doses (10, 30, or 75âmg) of mevidalen (LY3154207) or placebo for 12 weeks.OBJECTIVE:
To evaluate if frequent cognitive and motor tests using an iPad app and wrist-worn actigraphy to track activity and sleep could detect mevidalen treatment effects in LBD.METHODS:
Of 340 participants enrolled in PRESENCE, 238 wore actigraphy for three 2-week periods pre-, during, and post-intervention. A subset of participants (nâ=â160) enrolled in a sub-study using an iPad trial app with 3 tests digital symbol substitution (DSST), spatial working memory (SWM), and finger-tapping. Compliance was defined as daily test completion or watch-wearing ≥23âh/day. Change from baseline to week 12 (app) or week 8 (actigraphy) was used to assess treatment effects using Mixed Model Repeated Measures analysis. Pearson correlations between sensor-derived features and clinical endpoints were assessed.RESULTS:
Actigraphy and trial app compliance was >â90% and >â60%, respectively. At baseline, daytime sleep positively correlated with Epworth Sleepiness Scale score (pâ<â0.01). Physical activity correlated with improvement on Movement Disorder Society -Unified Parkinson Disease Rating Scale (MDS-UPDRS) part II (pâ<â0.001). Better scores of DSST and SWM correlated with lower Alzheimer Disease Assessment Scale -Cognitive 13-Item Scale (ADAS-Cog13) (pâ<â0.001). Mevidalen treatment (30âmg) improved SWM (pâ<â0.01), while dose-dependent decreases in daytime sleep (10âmg pâ<â0.01, 30âmg pâ<â0.05, 75âmg pâ<â0.001), and an increase in walking minutes (75âmg dose pâ<â0.001) were observed, returning to baseline post-intervention.CONCLUSION:
Devices used in the LBD population achieved adequate compliance and digital metrics detected statistically significant treatment effects.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Enfermedad de Parkinson
/
Fármacos Neuroprotectores
/
Enfermedad por Cuerpos de Lewy
Tipo de estudio:
Clinical_trials
/
Evaluation_studies
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
J Parkinsons Dis
Año:
2022
Tipo del documento:
Article
País de afiliación:
Estados Unidos