Effect of CAFfeine on Cognition in Alzheimer's Disease
- Registration Number
- NCT04570085
- Lead Sponsor
- University Hospital, Lille
- 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 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 248
- 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
-
Patients who refuse to adopt a low caffeine diet (eviction of tea, caffeinated sodas, chocolate in large quantities)
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Current major depressive episode according to DSM-5 criteria
-
Another chronic pathology of the central nervous system
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Major anxiety according to the clinician (consistent with the corresponding nPI-R items that must indicate a severity >2 and an impact >3)
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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)
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Decompensated heart disease or severe rhythm disorder (excluding slow, treated and stable chronic atrial fibrillation)
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Active smoking
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For childbearing women : pregnancy in progress or planned (A pregnancy test will be performed)
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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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Caffeine Caffeine after a 3 weeks up titration period, 1 capsule of 200 mg twice a day during 27 weeks (ie 400mg/day) placebo Placebo after a 3 weeks up titration period, 2 capsules per day during 27 weeks
- Primary Outcome Measures
Name Time Method Changes in NTB scores 30 weeks after randomization difference between randomized value and value after 30 weeks of treatment
- Secondary Outcome Measures
Name Time Method Caffeine treatment effect on TAP scores 30 weeks after randomization difference between randomized value and value after 30 weeks of treatment on TAP scores
persistent effect of caffeine treatment on TAP scores after a 6 weeks wash out period 36 weeks after randomization difference between value after 30 weeks of treatment and value after a 6 weeks wash out period (from Week 30 to Week 36) on TAP scores
Caffeine effect heterogeneity: impact of caffeine metabolism speed 30 weeks after randomization impact of caffeine metabolism on caffeine effect
persistent effect of caffeine treatment on Zarit score after a 6 weeks wash out period 36 weeks after randomization difference between value after 30 weeks of treatment and value after a 6 weeks wash out period (from Week 30 to Week 36) on Zarit score
Caffeine treatment effect on Epworth score 30 weeks after randomization difference between randomized value and value after 30 weeks of treatment on Epworth score
Caffeine treatment effect on QoL-AD score 30 weeks after randomization difference between randomized value and value after 30 weeks of treatment on QoL-AD score
Caffeine treatment effect on DAD-6 score 30 weeks after randomization difference between randomized value and value after 30 weeks of treatment on DAD-6 score
persistent effect of caffeine treatment on Epworth score after a 6 weeks wash out period 36 weeks after randomization difference between value after 30 weeks of treatment and value after a 6 weeks wash out period (from Week 30 to Week 36) on Epworth score
Caffeine treatment effect on MMSE score 30 weeks after randomization difference between randomized value and value after 30 weeks of treatment on MMSE score
Caffeine treatment effect on CGIC score 30 weeks after randomization difference between randomized value and value after 30 weeks of treatment on CGIC score
Caffeine treatment effect on Zarit score 30 weeks after randomization difference between randomized value and value after 30 weeks of treatment on Zarit score
persistent effect of caffeine treatment on MMSE score after a 6 weeks wash out period 36 weeks after randomization difference between value after 30 weeks of treatment and value after a 6 weeks wash out period (from Week 30 to Week 36) on MMSE score
persistent effect of caffeine treatment on QoL-AD score after a 6 weeks wash out period 36 weeks after randomization difference between value after 30 weeks of treatment and value after a 6 weeks wash out period (from Week 30 to Week 36) on QoL-AD score
Caffeine effect heterogeneity: impact of gender 30 weeks after randomization impact of gender on caffeine effect
Caffeine treatment effect on NTB subscores 30 weeks after randomization difference between randomized value and value after 30 weeks of treatment on NTB subscores
persistent effect of caffeine treatment on NTB subscores after a 6 weeks wash out period 36 weeks after randomization difference between value after 30 weeks of treatment and value after a 6 weeks wash out period (from Week 30 to Week 36) on NTB subscores
Caffeine safety profile: NPI scores 30 weeks after randomization changes in NPI scores and subscores between caffeine and placebo arms
Caffeine safety profile: heart beat 30 weeks after randomization changes in heart beat between caffeine and placebo arms
persistent effect of caffeine treatment on DAD-6 score after a 6 weeks wash out period 36 weeks after randomization difference between value after 30 weeks of treatment and value after a 6 weeks wash out period (from Week 30 to Week 36) on DAD-6 score
Caffeine effect heterogeneity: impact of AD treatment 30 weeks after randomization impact of AD treatment on caffeine effect
Caffeine effect heterogeneity: impact of ApoE4 status 30 weeks after randomization impact of ApoE4 status on caffeine effect
Caffeine safety profile: blood pressure 30 weeks after randomization changes in blood pressure between caffeine and placebo arms
Caffeine and its derivatives concentrations in blood samples 30 weeks after randomization increase in caffeinemia and its derivatives in the morning (fasting samples)
Trial Locations
- Locations (17)
CH Béthune
🇫🇷Béthune, France
CHU Caen
🇫🇷Caen, France
CHU Amiens
🇫🇷Amiens, France
CH Arras
🇫🇷Arras, France
CH Beauvais
🇫🇷Beauvais, France
CH Calais
🇫🇷Calais, France
CH Dunkerque
🇫🇷Dunkerque, France
CH Le Quesnoy
🇫🇷Le Quesnoy, France
Hôpital Roger Salengro
🇫🇷Lille, France
CH Lens
🇫🇷Lens, France
CHU Lille consultation mémoire Les Bâteliers
🇫🇷Lille, France
CH Roubaix
🇫🇷Roubaix, France
CHU Rouen
🇫🇷Rouen, France
CH Saint Quentin
🇫🇷Saint-Quentin, France
CH Seclin
🇫🇷Seclin, France
CH Tourcoing
🇫🇷Tourcoing, France
CH Valenciennes
🇫🇷Valenciennes, France