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RECRUITING
NCT04570085
PHASE3

Effect of CAFfeine on Cognition in Alzheimer's Disease

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

Summary

Sporadic Alzheimer's disease is a multifactorial illness arising a major medico-economic stakes for our aging societies. There is currently no curative treatment available. Coffee is a complex beverage with psychostimulant properties whose main effective element, caffeine, has a pleiotropic effect on the central nervous system. Caffeine pharmacological properties enable its use like an Alzheimer's disease symptomatic treatment. Its supposed benefits mustn't obscure anxiety and insomnia caffeine effect at large dose, which Alzheimer's patients might be more vulnerable. The main study objective is to evaluate placebo-controlled caffeine efficacy (30 treatments weeks) on cognitive decline in Alzheimer's disease dementia at beginning to moderate stage (MMSE 16-24).

Official title: Multicentre, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Effect of a 30-week Caffeine Treatment on Cognition in Alzheimer's Disease at Beginning to Moderate Stages

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2021-03-01

Completion Date

2026-11

Last Updated

2025-04-11

Healthy Volunteers

No

Interventions

DRUG

Caffeine

100mg caffeine capsule treatment, beginning after caffeine diet during 6 weeks, titrate in 3 weeks (by 100mg stages) until 400mg aim dose per day in 2 doses during 27 weeks, and finally interrupt according to the same negative titration.

DRUG

Placebo

Placebo capsule treatment, beginning after caffeine diet during 6 weeks, titrate in 3 weeks until 2 doses aim dose per day during 27 weeks, and finally interrupt according to the same negative titration.

Locations (17)

CHU Amiens

Amiens, France

CH Arras

Arras, France

CH Beauvais

Beauvais, France

CH Béthune

Béthune, France

CHU Caen

Caen, France

CH Calais

Calais, France

CH Dunkerque

Dunkirk, France

CH Le Quesnoy

Le Quesnoy, France

CH Lens

Lens, France

Hôpital Roger Salengro

Lille, France

CHU Lille consultation mémoire Les Bâteliers

Lille, France

CH Roubaix

Roubaix, France

CHU Rouen

Rouen, France

CH Saint Quentin

Saint-Quentin, France

CH Seclin

Seclin, France

CH Tourcoing

Tourcoing, France

CH Valenciennes

Valenciennes, France