Tests caffeine against placebo for thinking decline in early Alzheimer's
Tests caffeine against a placebo in adults with early to moderate Alzheimer's disease.
Plain-language title generated from the registry record
Registry title: Effect of CAFfeine on Cognition in Alzheimer's Disease
Key facts
- Where
- Amiens, Arras, Beauvais, Béthune, Caen, Calais, Dunkirk, Le Quesnoy, Lens, Lille, Roubaix, Rouen, Saint-Quentin, Seclin, Tourcoing, and Valenciennes, FranceSee the 17 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 50 or older with probable Alzheimer's dementia at an early to moderate stage. A caregiver who lives with the person must take part too.
- Age
- 50 years or older
- Sex
- All sexes
- Disease stage
- Probable Alzheimer's dementia, supported by brain imaging and blood tests done in routine care. MMSE score of 16 or higher (the summary gives the range 16-24).
- Earlier treatment
- Treatment with IAChE and/or Memantine is not required. If the person takes it, it must have worked and stayed stable for 2 months before the selection visit, and stay stable during the study.
Main reasons for not taking part
- Refusing to follow a low caffeine diet
- Current major depressive episode
- Another long-term disease of the central nervous system
- Major anxiety or sleep disorders (with some exceptions)
- Active smoking
Read by machine on 12 November 2026.
Where in France
- CHU AmiensAmiens, FranceContact: Olivier GODEFROY, MDNot yet recruiting
- CH ArrasArras, FranceContact: Patrick LE COZ, MDNot yet recruiting
- CH BeauvaisBeauvais, FranceContact: Xavier CNOCKAERT, MDNot yet recruiting
- CH BéthuneBéthune, FranceContact: Isabelle LAVENU, MDNot yet recruiting
- CHU CaenCaen, FranceContact: Olivier MARTINAUD, MDNot yet recruiting
- CH CalaisCalais, FranceContact: Olivier DEREEPER, MDNot yet recruiting
- CH DunkerqueDunkirk, FranceContact: Abdelghani EL AZOUZI, MDNot yet recruiting
- CH Le QuesnoyLe Quesnoy, FranceContact: Denis LEFEBVRE, MDNot yet recruiting
- CH LensLens, FranceContact: Olivier SENECHAL, MDNot yet recruiting
- CHU Lille consultation mémoire Les BâteliersLille, FranceContact: Dominique HUVENT, MDNot yet recruiting
- Hopital Roger SalengroLille, FranceContact: Thibaut Lebouvier, MD (principal investigator)Taking people
- CH RoubaixRoubaix, FranceContact: Pierre FORZY, MDNot yet recruiting
- CHU RouenRouen, FranceContact: David WALLON, MDNot yet recruiting
- CH Saint QuentinSaint-Quentin, FranceContact: Jadwiga ATTIER-ZMUDKA, MDNot yet recruiting
- CH SeclinSeclin, FranceContact: Véronique BERRIOT, MDNot yet recruiting
- CH TourcoingTourcoing, FranceContact: Karim GALLOUJ, MDNot yet recruiting
- CH ValenciennesValenciennes, FranceContact: Anne DESPREZ, MDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Lille
- Trial code
- NCT04570085
- Record updated
- 20 April 2026
- Original description
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.Read full original descriptionShow less
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
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).
Inclusion: 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: 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; 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); 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).