Caffeine's effect on cognitive decline in Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy of caffeine as a symptomatic treatment for cognitive decline in patients with Alzheimer's disease. It is a Phase 3, placebo-controlled study that will administer caffeine over a 30-week period to assess its impact on cognitive function in individuals with mild to moderate Alzheimer's disease. Participants must meet specific diagnostic criteria and undergo routine health assessments to ensure eligibility. The study aims to determine whether caffeine can provide cognitive benefits while considering potential side effects such as anxiety and insomnia.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Roger Salengro
  Lille, France Recruiting
• 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

Study contacts

• Principal investigator: thibaud LEBOUVIER, MD,PhD — University Hospital, Lille
• Study coordinator: Thibaud LEBOUVIER, MD,PhD
• Email: thibaud.lebouvier@chru-lille.fr
• Phone: 03 20 44 60 21

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.