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
- Diseases
- Alzheimer disease
- 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
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Not yet recruiting |
| CH Arras Coordinator of this site? Confirm its status | Arras | France | Not yet recruiting |
| CH Beauvais Coordinator of this site? Confirm its status | Beauvais | France | Not yet recruiting |
| CH Béthune Coordinator of this site? Confirm its status | Béthune | France | Not yet recruiting |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Not yet recruiting |
| CH Calais Coordinator of this site? Confirm its status | Calais | France | Not yet recruiting |
| CH Dunkerque Coordinator of this site? Confirm its status | Dunkirk | France | Not yet recruiting |
| CH Lens Coordinator of this site? Confirm its status | Lens | France | Not yet recruiting |
| CH Le Quesnoy Coordinator of this site? Confirm its status | Le Quesnoy | France | Not yet recruiting |
| CHU Lille consultation mémoire Les Bâteliers Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Hopital Roger Salengro Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CH Roubaix Coordinator of this site? Confirm its status | Roubaix | France | Not yet recruiting |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Not yet recruiting |
| CH Saint Quentin Coordinator of this site? Confirm its status | Saint-Quentin | France | Not yet recruiting |
| CH Seclin Coordinator of this site? Confirm its status | Seclin | France | Not yet recruiting |
| CH Tourcoing Coordinator of this site? Confirm its status | Tourcoing | France | Not yet recruiting |
| CH Valenciennes Coordinator of this site? Confirm its status | Valenciennes | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.