Effect of CAFfeine on Cognition in Alzheimer's Disease

Phase 3RecruitingNCT04570085

University Hospital, Lille248 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

248

Conditions

Alzheimer Disease

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (17)

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

...and 7 more locations

Outcomes

Primary Outcomes

Changes in NTB scores

difference between randomized value and value after 30 weeks of treatment

Time frame: 30 weeks after randomization

Secondary Outcomes

Caffeine treatment effect on MMSE score

difference between randomized value and value after 30 weeks of treatment on MMSE score

Time frame: 30 weeks after randomization

Caffeine treatment effect on NTB subscores

difference between randomized value and value after 30 weeks of treatment on NTB subscores

Time frame: 30 weeks after randomization

Caffeine treatment effect on TAP scores

difference between randomized value and value after 30 weeks of treatment on TAP scores

Time frame: 30 weeks after randomization

Caffeine treatment effect on Epworth score

difference between randomized value and value after 30 weeks of treatment on Epworth score

Time frame: 30 weeks after randomization

Caffeine treatment effect on DAD-6 score

difference between randomized value and value after 30 weeks of treatment on DAD-6 score

Time frame: 30 weeks after randomization

Caffeine treatment effect on QoL-AD score

difference between randomized value and value after 30 weeks of treatment on QoL-AD score

Time frame: 30 weeks after randomization

Caffeine treatment effect on CGIC score

difference between randomized value and value after 30 weeks of treatment on CGIC score

Time frame: 30 weeks after randomization

Caffeine treatment effect on Zarit score

difference between randomized value and value after 30 weeks of treatment on Zarit score

Time frame: 30 weeks after randomization

persistent effect of caffeine treatment on MMSE score after a 6 weeks wash out period

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

Time frame: 36 weeks after randomization

persistent effect of caffeine treatment on NTB subscores after a 6 weeks wash out period

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

Time frame: 36 weeks after randomization

persistent effect of caffeine treatment on TAP scores after a 6 weeks wash out period

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

Time frame: 36 weeks after randomization

persistent effect of caffeine treatment on Epworth score after a 6 weeks wash out period

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

Time frame: 36 weeks after randomization

persistent effect of caffeine treatment on DAD-6 score after a 6 weeks wash out period

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

Time frame: 36 weeks after randomization

persistent effect of caffeine treatment on QoL-AD score after a 6 weeks wash out period

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

Time frame: 36 weeks after randomization

persistent effect of caffeine treatment on Zarit score after a 6 weeks wash out period

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

Time frame: 36 weeks after randomization

Caffeine effect heterogeneity: impact of AD treatment

impact of AD treatment on caffeine effect

Time frame: 30 weeks after randomization

Caffeine effect heterogeneity: impact of ApoE4 status

impact of ApoE4 status on caffeine effect

Time frame: 30 weeks after randomization

Caffeine effect heterogeneity: impact of caffeine metabolism speed

impact of caffeine metabolism on caffeine effect

Time frame: 30 weeks after randomization

Caffeine effect heterogeneity: impact of gender

impact of gender on caffeine effect

Time frame: 30 weeks after randomization

Caffeine safety profile: NPI scores

changes in NPI scores and subscores between caffeine and placebo arms

Time frame: 30 weeks after randomization

Caffeine safety profile: heart beat

changes in heart beat between caffeine and placebo arms

Time frame: 30 weeks after randomization

Caffeine safety profile: blood pressure

changes in blood pressure between caffeine and placebo arms

Time frame: 30 weeks after randomization

Caffeine and its derivatives concentrations in blood samples

increase in caffeinemia and its derivatives in the morning (fasting samples)

Time frame: 30 weeks after randomization

Effect of CAFfeine on Cognition in Alzheimer's Disease

Overview

Conditions

Interventions

Eligibility

Locations (17)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts