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NCT04570085RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 20 Apr 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
248 (estimated)
First submitted
8 Jun 2020
Start date
1 Mar 2021
Primary completion date
31 Dec 2027
Lead sponsor
University Hospital, Lille
NCT number
NCT04570085
EudraCT number
2019-002360-27

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 248
  • From 1 Mar 2021 to the primary completion date, 31 Dec 2027
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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)

Other

  • 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)
  • Active smoking
  • For childbearing women : pregnancy in progress or planned (A pregnancy test will be performed)

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Amiens
Coordinator of this site? Confirm its status
AmiensFranceNot yet recruiting
CH Arras
Coordinator of this site? Confirm its status
ArrasFranceNot yet recruiting
CH Beauvais
Coordinator of this site? Confirm its status
BeauvaisFranceNot yet recruiting
CH Béthune
Coordinator of this site? Confirm its status
BéthuneFranceNot yet recruiting
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceNot yet recruiting
CH Calais
Coordinator of this site? Confirm its status
CalaisFranceNot yet recruiting
CH Dunkerque
Coordinator of this site? Confirm its status
DunkirkFranceNot yet recruiting
CH Lens
Coordinator of this site? Confirm its status
LensFranceNot yet recruiting
CH Le Quesnoy
Coordinator of this site? Confirm its status
Le QuesnoyFranceNot yet recruiting
CHU Lille consultation mémoire Les Bâteliers
Coordinator of this site? Confirm its status
LilleFranceNot yet recruiting
Hopital Roger Salengro
Coordinator of this site? Confirm its status
LilleFranceRecruiting
CH Roubaix
Coordinator of this site? Confirm its status
RoubaixFranceNot yet recruiting
CHU Rouen
Coordinator of this site? Confirm its status
RouenFranceNot yet recruiting
CH Saint Quentin
Coordinator of this site? Confirm its status
Saint-QuentinFranceNot yet recruiting
CH Seclin
Coordinator of this site? Confirm its status
SeclinFranceNot yet recruiting
CH Tourcoing
Coordinator of this site? Confirm its status
TourcoingFranceNot yet recruiting
CH Valenciennes
Coordinator of this site? Confirm its status
ValenciennesFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.