Phase
Condition
N/ATreatment
Caffeine
Placebo
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 50 at screening
Probable Alzheimer dementia according to the criteria of the National Institute onAging-Alzheimer's Association; diagnosis must be supported by brain imaging (CT orMRI) 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 beeffective and stable for 2 months before the selection visit and must remain stablefor the duration of the study
Exclusion
Exclusion Criteria:
Patients who refuse to adopt a low caffeine diet (eviction of tea, caffeinatedsodas, 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-Ritems 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 OSAmay 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 andstable chronic atrial fibrillation)
Active smoking
For childbearing women : pregnancy in progress or planned (A pregnancy test will beperformed)
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
Study Design
Connect with a study center
CHU Amiens
Amiens,
FranceSite Not Available
CH Arras
Arras,
FranceSite Not Available
CH Beauvais
Beauvais,
FranceSite Not Available
CH Béthune
Béthune,
FranceSite Not Available
CHU Caen
Caen,
FranceSite Not Available
CH Calais
Calais,
FranceSite Not Available
CH Dunkerque
Dunkerque,
FranceSite Not Available
CH Le Quesnoy
Le Quesnoy,
FranceSite Not Available
CH Lens
Lens,
FranceSite Not Available
CHU Lille consultation mémoire Les Bâteliers
Lille,
FranceSite Not Available
Hôpital Roger Salengro
Lille, 59037
FranceActive - Recruiting
CH Roubaix
Roubaix,
FranceSite Not Available
CHU Rouen
Rouen,
FranceSite Not Available
CH Saint Quentin
Saint-Quentin,
FranceSite Not Available
CH Seclin
Seclin,
FranceSite Not Available
CH Tourcoing
Tourcoing,
FranceSite Not Available
CH Valenciennes
Valenciennes,
FranceSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.