Effect of CAFfeine on Cognition in Alzheimer's Disease

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Caffeine
  100mg caffeine capsule treatment, beginning after caffeine diet during 6 weeks, titrate in 3 weeks (by 100mg stages) until 400mg aim dose per day in 2 doses during 27 weeks, and finally interrupt according to the same negative titration.
• Препарат Placebo
  Placebo capsule treatment, beginning after caffeine diet during 6 weeks, titrate in 3 weeks until 2 doses aim dose per day during 27 weeks, and finally interrupt according to the same negative titration.

Первичные конечные точки

• Changes in NTB scores [Срок оценки: 30 weeks after randomization]

Вторичные конечные точки (12)

• Caffeine treatment effect on MMSE score [Срок оценки: 30 weeks after randomization]
• Caffeine treatment effect on NTB subscores [Срок оценки: 30 weeks after randomization]
• Caffeine treatment effect on TAP scores [Срок оценки: 30 weeks after randomization]
• Caffeine treatment effect on Epworth score [Срок оценки: 30 weeks after randomization]
• Caffeine treatment effect on DAD-6 score [Срок оценки: 30 weeks after randomization]
• Caffeine treatment effect on QoL-AD score [Срок оценки: 30 weeks after randomization]
• Caffeine treatment effect on CGIC score [Срок оценки: 30 weeks after randomization]
• Caffeine treatment effect on Zarit score [Срок оценки: 30 weeks after randomization]
• persistent effect of caffeine treatment on MMSE score after a 6 weeks wash out period [Срок оценки: 36 weeks after randomization]
• persistent effect of caffeine treatment on NTB subscores after a 6 weeks wash out period [Срок оценки: 36 weeks after randomization]
• persistent effect of caffeine treatment on TAP scores after a 6 weeks wash out period [Срок оценки: 36 weeks after randomization]
• persistent effect of caffeine treatment on Epworth score after a 6 weeks wash out period [Срок оценки: 36 weeks after randomization]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 17 центров

• CHU Amiens — Amiens
• CH Arras — Arras
• CH Beauvais — Beauvais
• CH Béthune — Béthune
• CHU Caen — Caen
• CH Calais — Calais
• CH Dunkerque — Dunkirk
• CH Le Quesnoy — Le Quesnoy
• … и ещё 9 центров

Идентификаторы

NCT: NCT04570085 · 2018_95 · 2019-002360-27

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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