RecruitingPhase 3NCT04570085

Effect of CAFfeine on Cognition in Alzheimer's Disease

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


Sponsor

University Hospital, Lille

Enrollment

248 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether caffeine can improve memory and thinking in people with Alzheimer's disease. Caffeine affects certain brain receptors that are involved in memory, and researchers want to know if it could be a safe and helpful treatment. **You may be eligible if...** - You are 50 years old or older - You have been diagnosed with probable Alzheimer's dementia, confirmed by brain imaging - Your memory score (MMSE) is 16 or higher, meaning you have mild to moderate symptoms - You have a caregiver or family member who lives with you and can participate - You are willing to follow a low-caffeine diet during the study (cutting out tea, caffeinated sodas, and large amounts of chocolate) **You may NOT be eligible if...** - You are currently experiencing a major depressive episode - You have another brain or nervous system condition - You have severe anxiety or sleep disorders - You have uncontrolled heart disease or serious heart rhythm problems - You currently smoke - You are pregnant or planning to become pregnant - You take medications that interact with caffeine metabolism Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCaffeine

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.

DRUGPlacebo

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

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NCT04570085


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