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Effect of CAFfeine on Cognition in Alzheimer's Disease

NCT04570085 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2026-04-20

No results posted yet for this study

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).

Conditions

  • Alzheimer Disease

Interventions

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.

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.

Sponsors & Collaborators

  • Groupement Interrégional de Recherche Clinique et d'Innovation

    collaborator OTHER

  • Laboratory of excellence DISTALZ

    collaborator UNKNOWN

  • Région Nord-Pas de Calais, France

    collaborator OTHER

  • Meo coffee

    collaborator UNKNOWN

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • thibaud LEBOUVIER, MD,PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04570085 on ClinicalTrials.gov