Caffeine's effect on cognitive decline 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
This study is testing if caffeine can help improve thinking and memory in people with mild to moderate Alzheimer's disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 17 sites (Amiens and 16 other locations) |
| Trial ID | NCT04570085 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of caffeine as a symptomatic treatment for cognitive decline in patients with Alzheimer's disease. It is a Phase 3, placebo-controlled study that will administer caffeine over a 30-week period to assess its impact on cognitive function in individuals with mild to moderate Alzheimer's disease. Participants must meet specific diagnostic criteria and undergo routine health assessments to ensure eligibility. The study aims to determine whether caffeine can provide cognitive benefits while considering potential side effects such as anxiety and insomnia.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with a diagnosis of probable Alzheimer's dementia and a Mini-Mental State Examination (MMSE) score between 16 and 24.
Not a fit: Patients with major depressive episodes, other chronic central nervous system pathologies, or those unable to adhere to a low caffeine diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new symptomatic treatment option for patients with Alzheimer's disease, potentially improving their cognitive function.
How similar studies have performed: While caffeine has been studied for its cognitive effects, this specific approach in Alzheimer's disease is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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) * 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) * Active smoking * For childbearing women : pregnancy in progress or planned (A pregnancy test will be performed) * 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
Where this trial is running
Amiens and 16 other locations
- CHU Amiens — Amiens, France (Not_yet_recruiting)
- CH Arras — Arras, France (Not_yet_recruiting)
- CH Beauvais — Beauvais, France (Not_yet_recruiting)
- CH Béthune — Béthune, France (Not_yet_recruiting)
- CHU Caen — Caen, France (Not_yet_recruiting)
- CH Calais — Calais, France (Not_yet_recruiting)
- CH Dunkerque — Dunkirk, France (Not_yet_recruiting)
- CH Le Quesnoy — Le Quesnoy, France (Not_yet_recruiting)
- CH Lens — Lens, France (Not_yet_recruiting)
- Hôpital Roger Salengro — Lille, France (Recruiting)
- CHU Lille consultation mémoire Les Bâteliers — Lille, France (Not_yet_recruiting)
- CH Roubaix — Roubaix, France (Not_yet_recruiting)
- CHU Rouen — Rouen, France (Not_yet_recruiting)
- CH Saint Quentin — Saint-Quentin, France (Not_yet_recruiting)
- CH Seclin — Seclin, France (Not_yet_recruiting)
- CH Tourcoing — Tourcoing, France (Not_yet_recruiting)
- CH Valenciennes — Valenciennes, France (Not_yet_recruiting)
Study contacts
- Principal investigator: thibaud LEBOUVIER, MD,PhD — University Hospital, Lille
- Study coordinator: Thibaud LEBOUVIER, MD,PhD
- Email: thibaud.lebouvier@chru-lille.fr
- Phone: 03 20 44 60 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.