Status:
RECRUITING
Effect of CAFfeine on Cognition in Alzheimer's Disease
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Groupement Interrégional de Recherche Clinique et d'Innovation
Laboratory of excellence DISTALZ
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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 bevera...
Eligibility Criteria
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 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04570085
Start Date
March 1 2021
End Date
November 1 2026
Last Update
April 11 2025
Active Locations (17)
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1
CHU Amiens
Amiens, France
2
CH Arras
Arras, France
3
CH Beauvais
Beauvais, France
4
CH Béthune
Béthune, France