Effect of CAFfeine on Cognition in Alzheimer's Disease

Last updated: April 10, 2025
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Caffeine

Placebo

Clinical Study ID

NCT04570085
2018_95
2019-002360-27
  • Ages > 50
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 50 at screening

  • Probable Alzheimer dementia according to the criteria of the National Institute onAging-Alzheimer's Association; diagnosis must be supported by brain imaging (CT orMRI) 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 beeffective and stable for 2 months before the selection visit and must remain stablefor the duration of the study

Exclusion

Exclusion Criteria:

  • Patients who refuse to adopt a low caffeine diet (eviction of tea, caffeinatedsodas, 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-Ritems 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 OSAmay 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 andstable chronic atrial fibrillation)

  • Active smoking

  • For childbearing women : pregnancy in progress or planned (A pregnancy test will beperformed)

  • 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

Study Design

Total Participants: 248
Treatment Group(s): 2
Primary Treatment: Caffeine
Phase: 3
Study Start date:
March 01, 2021
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • CHU Amiens

    Amiens,
    France

    Site Not Available

  • CH Arras

    Arras,
    France

    Site Not Available

  • CH Beauvais

    Beauvais,
    France

    Site Not Available

  • CH Béthune

    Béthune,
    France

    Site Not Available

  • CHU Caen

    Caen,
    France

    Site Not Available

  • CH Calais

    Calais,
    France

    Site Not Available

  • CH Dunkerque

    Dunkerque,
    France

    Site Not Available

  • CH Le Quesnoy

    Le Quesnoy,
    France

    Site Not Available

  • CH Lens

    Lens,
    France

    Site Not Available

  • CHU Lille consultation mémoire Les Bâteliers

    Lille,
    France

    Site Not Available

  • Hôpital Roger Salengro

    Lille, 59037
    France

    Active - Recruiting

  • CH Roubaix

    Roubaix,
    France

    Site Not Available

  • CHU Rouen

    Rouen,
    France

    Site Not Available

  • CH Saint Quentin

    Saint-Quentin,
    France

    Site Not Available

  • CH Seclin

    Seclin,
    France

    Site Not Available

  • CH Tourcoing

    Tourcoing,
    France

    Site Not Available

  • CH Valenciennes

    Valenciennes,
    France

    Site Not Available

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