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Coffee as medicine? major trial tests caffeine against Alzheimer's

NCT ID NCT04570085

Symptom relief Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking caffeine for 30 weeks can slow down memory and thinking problems in people with early-to-moderate Alzheimer's disease. About 248 adults aged 50 and older will receive either caffeine pills or a placebo (dummy pill) to see if caffeine helps keep their minds sharper. The goal is to find a safe, easy-to-use option to ease symptoms, not to cure the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 248 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 50 at screening * Probable Alzheimer dementia according to the criteria of the National Institute on Aging-Alzheimer's Association; diagnosis must be supported by brain imaging (CT or MRI) and blood test (including ionogram, kidney and liver function, calcemia, CRP, TSH, B12 vitamins and folates) performed in routine care * MMSE score ≥16 * Presence of an informant and caregiver, living with the patient * IAChE and/or Memantine treatment non-compulsory ; If implemented it must be effective and stable for 2 months before the selection visit and must remain stable for the duration of the study Exclusion Criteria: * Patients who refuse to adopt a low caffeine diet (eviction of tea, caffeinated sodas, chocolate in large quantities) * Current major depressive episode according to DSM-5 criteria * Another chronic pathology of the central nervous system * Major anxiety according to the clinician (consistent with the corresponding nPI-R items that must indicate a severity \>2 and an impact \>3) * Sleep disorders defined by severity and an impact on NPI-R; a patient fitted for OSA may be included if the device has been in use for 3 months and well tolerated (stable) * Decompensated heart disease or severe rhythm disorder (excluding slow, treated and stable chronic atrial fibrillation) * Active smoking * For childbearing women : pregnancy in progress or planned (A pregnancy test will be performed) * Patients who take forbidden treatment : * Psychotropic treatments introduced or modified \< 2 months before inclusion * Chronic use of CYP1A2 inducing or inhibiting drugs * All caffeine-containing specialties * Drugs that influence caffeine metabolism * Drugs that may interact with caffeine

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Arras

    NOT_YET_RECRUITING

    Arras, France

  • CH Beauvais

    NOT_YET_RECRUITING

    Beauvais, France

  • CH Béthune

    NOT_YET_RECRUITING

    Béthune, France

  • CH Calais

    NOT_YET_RECRUITING

    Calais, France

  • CH Dunkerque

    NOT_YET_RECRUITING

    Dunkirk, France

  • CH Le Quesnoy

    NOT_YET_RECRUITING

    Le Quesnoy, France

  • CH Lens

    NOT_YET_RECRUITING

    Lens, France

  • CH Roubaix

    NOT_YET_RECRUITING

    Roubaix, France

  • CH Saint Quentin

    NOT_YET_RECRUITING

    Saint-Quentin, France

  • CH Seclin

    NOT_YET_RECRUITING

    Seclin, France

  • CH Tourcoing

    NOT_YET_RECRUITING

    Tourcoing, France

  • CH Valenciennes

    NOT_YET_RECRUITING

    Valenciennes, France

  • CHU Amiens

    NOT_YET_RECRUITING

    Amiens, France

  • CHU Caen

    NOT_YET_RECRUITING

    Caen, France

  • CHU Lille consultation mémoire Les Bâteliers

    NOT_YET_RECRUITING

    Lille, France

  • CHU Rouen

    NOT_YET_RECRUITING

    Rouen, France

  • Hôpital Roger Salengro

    RECRUITING

    Lille, 59037, France

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