Actively Recruiting
Effect of CAFfeine on Cognition in Alzheimer's Disease
Led by University Hospital, Lille · Updated on 2026-04-20
248
Participants Needed
17
Research Sites
352 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
G
Groupement Interrégional de Recherche Clinique et d'Innovation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Effect of CAFfeine on Cognition in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older at screening
- Probable Alzheimer's dementia diagnosed according to National Institute on Aging-Alzheimer's Association criteria, confirmed by brain imaging (CT or MRI) and blood tests including ionogram, kidney and liver function, calcemia, CRP, TSH, B12 vitamins, and folates
- Mini-Mental State Examination (MMSE) score of 16 or higher
- Presence of an informant and caregiver living with the patient
- If using acetylcholinesterase inhibitors and/or memantine, treatment must be stable and effective for at least 2 months before selection and remain stable during the study
You will not qualify if you...
- Refusal to follow a low caffeine diet (avoiding tea, caffeinated sodas, and large amounts of chocolate)
- Current major depressive episode as defined by DSM-5 criteria
- Other chronic central nervous system disorders
- Major anxiety diagnosed by clinician with severity >2 and impact >3 on NPI-R scale
- Sleep disorders with severity and impact on NPI-R; patients with obstructive sleep apnea may participate if device has been used and tolerated for 3 months
- Decompensated heart disease or severe rhythm disorders (except stable chronic atrial fibrillation)
- Active smoking
- Pregnant or planning pregnancy (pregnancy test required for women of childbearing potential)
- Use of forbidden treatments including psychotropic drugs introduced or changed less than 2 months before inclusion, chronic use of CYP1A2 inducers or inhibitors, any caffeine-containing products, drugs affecting caffeine metabolism, or drugs interacting with caffeine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
CHU Amiens
Amiens, France
Not Yet Recruiting
2
CH Arras
Arras, France
Not Yet Recruiting
3
CH Beauvais
Beauvais, France
Not Yet Recruiting
4
CH Béthune
Béthune, France
Not Yet Recruiting
5
CHU Caen
Caen, France
Not Yet Recruiting
6
CH Calais
Calais, France
Not Yet Recruiting
7
CH Dunkerque
Dunkirk, France
Not Yet Recruiting
8
CH Le Quesnoy
Le Quesnoy, France
Not Yet Recruiting
9
CH Lens
Lens, France
Not Yet Recruiting
10
Hôpital Roger Salengro
Lille, France, 59037
Actively Recruiting
11
CHU Lille consultation mémoire Les Bâteliers
Lille, France
Not Yet Recruiting
12
CH Roubaix
Roubaix, France
Not Yet Recruiting
13
CHU Rouen
Rouen, France
Not Yet Recruiting
14
CH Saint Quentin
Saint-Quentin, France
Not Yet Recruiting
15
CH Seclin
Seclin, France
Not Yet Recruiting
16
CH Tourcoing
Tourcoing, France
Not Yet Recruiting
17
CH Valenciennes
Valenciennes, France
Not Yet Recruiting
Research Team
T
Thibaud LEBOUVIER, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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