Effect of CAFfeine on Cognition in Alzheimer's Disease (CAFCA)

April 17, 2026 updated by: University Hospital, Lille

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • CHU Amiens
        • Contact:
          • Olivier GODEFROY, MD
      • Arras, France
        • Not yet recruiting
        • CH ARRAS
        • Contact:
          • Patrick LE COZ, MD
      • Beauvais, France
        • Not yet recruiting
        • CH Beauvais
        • Contact:
          • Xavier CNOCKAERT, MD
      • Béthune, France
        • Not yet recruiting
        • CH Bethune
        • Contact:
          • Isabelle LAVENU, MD
      • Caen, France
        • Not yet recruiting
        • CHU caen
        • Contact:
          • Olivier MARTINAUD, MD
      • Calais, France
        • Not yet recruiting
        • CH Calais
        • Contact:
          • Olivier DEREEPER, MD
      • Dunkirk, France
        • Not yet recruiting
        • Ch Dunkerque
        • Contact:
          • Abdelghani EL AZOUZI, MD
      • Le Quesnoy, France
        • Not yet recruiting
        • CH Le Quesnoy
        • Contact:
          • Denis LEFEBVRE, MD
      • Lens, France
        • Not yet recruiting
        • CH LENS
        • Contact:
          • Olivier SENECHAL, MD
      • Lille, France, 59037
        • Recruiting
        • Hôpital Roger Salengro
        • Principal Investigator:
          • Thibaut Lebouvier, MD
      • Lille, France
        • Not yet recruiting
        • CHU Lille consultation mémoire Les Bâteliers
        • Contact:
          • Dominique HUVENT, MD
      • Roubaix, France
        • Not yet recruiting
        • CH Roubaix
        • Contact:
          • Pierre FORZY, MD
      • Rouen, France
        • Not yet recruiting
        • CHU Rouen
        • Contact:
          • David WALLON, MD
      • Saint-Quentin, France
        • Not yet recruiting
        • CH Saint Quentin
        • Contact:
          • Jadwiga ATTIER-ZMUDKA, MD
      • Seclin, France
        • Not yet recruiting
        • CH Seclin
        • Contact:
          • Véronique BERRIOT, MD
      • Tourcoing, France
        • Not yet recruiting
        • Ch Tourcoing
        • Contact:
          • Karim GALLOUJ, MD
      • Valenciennes, France
        • Not yet recruiting
        • Ch Valenciennes
        • Contact:
          • Anne DESPREZ, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Caffeine
after a 3 weeks up titration period, 1 capsule of 200 mg twice a day during 27 weeks (ie 400mg/day)
Drug: 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.
Placebo Comparator: placebo
after a 3 weeks up titration period, 2 capsules per day during 27 weeks
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in NTB scores
Time Frame: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment
30 weeks after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caffeine treatment effect on MMSE score
Time Frame: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment on MMSE score
30 weeks after randomization
Caffeine treatment effect on NTB subscores
Time Frame: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment on NTB subscores
30 weeks after randomization
Caffeine treatment effect on TAP scores
Time Frame: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment on TAP scores
30 weeks after randomization
Caffeine treatment effect on Epworth score
Time Frame: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment on Epworth score
30 weeks after randomization
Caffeine treatment effect on DAD-6 score
Time Frame: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment on DAD-6 score
30 weeks after randomization
Caffeine treatment effect on QoL-AD score
Time Frame: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment on QoL-AD score
30 weeks after randomization
Caffeine treatment effect on CGIC score
Time Frame: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment on CGIC score
30 weeks after randomization
Caffeine treatment effect on Zarit score
Time Frame: 30 weeks after randomization
difference between randomized value and value after 30 weeks of treatment on Zarit score
30 weeks after randomization
persistent effect of caffeine treatment on MMSE score after a 6 weeks wash out period
Time Frame: 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
36 weeks after randomization
persistent effect of caffeine treatment on NTB subscores after a 6 weeks wash out period
Time Frame: 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
36 weeks after randomization
persistent effect of caffeine treatment on TAP scores after a 6 weeks wash out period
Time Frame: 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
36 weeks after randomization
persistent effect of caffeine treatment on Epworth score after a 6 weeks wash out period
Time Frame: 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
36 weeks after randomization
persistent effect of caffeine treatment on DAD-6 score after a 6 weeks wash out period
Time Frame: 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
36 weeks after randomization
persistent effect of caffeine treatment on QoL-AD score after a 6 weeks wash out period
Time Frame: 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
36 weeks after randomization
persistent effect of caffeine treatment on Zarit score after a 6 weeks wash out period
Time Frame: 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
36 weeks after randomization
Caffeine effect heterogeneity: impact of AD treatment
Time Frame: 30 weeks after randomization
impact of AD treatment on caffeine effect
30 weeks after randomization
Caffeine effect heterogeneity: impact of ApoE4 status
Time Frame: 30 weeks after randomization
impact of ApoE4 status on caffeine effect
30 weeks after randomization
Caffeine effect heterogeneity: impact of caffeine metabolism speed
Time Frame: 30 weeks after randomization
impact of caffeine metabolism on caffeine effect
30 weeks after randomization
Caffeine effect heterogeneity: impact of gender
Time Frame: 30 weeks after randomization
impact of gender on caffeine effect
30 weeks after randomization
Caffeine safety profile: NPI scores
Time Frame: 30 weeks after randomization
changes in NPI scores and subscores between caffeine and placebo arms
30 weeks after randomization
Caffeine safety profile: heart beat
Time Frame: 30 weeks after randomization
changes in heart beat between caffeine and placebo arms
30 weeks after randomization
Caffeine safety profile: blood pressure
Time Frame: 30 weeks after randomization
changes in blood pressure between caffeine and placebo arms
30 weeks after randomization
Caffeine and its derivatives concentrations in blood samples
Time Frame: 30 weeks after randomization
increase in caffeinemia and its derivatives in the morning (fasting samples)
30 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Groupement Interrégional de Recherche Clinique et d'Innovation
Région Nord-Pas de Calais, France
Laboratory of excellence DISTALZ
Meo coffee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thibaud LEBOUVIER, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018_95
  • 2019-002360-27 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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