AzTrials
AzTrials

Alzheimer DiseasePhase 3CAFCANCT04570085

Effect of CAFfeine on Cognition in Alzheimer's Disease

A Phase 3 study testing Caffeine in people with Alzheimer Disease, run by University Hospital, Lille at 17 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
Caffeine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
17 sitesFrance
Study dates
1 Mar 2021to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Thibaud LEBOUVIER, MD,PhD contact

03 20 44 60 21 ext. +33

thibaud.lebouvier@chru-lille.fr

17 sites in 1 country

France17 sites, 17 recruiting

  • CHU Amiens

    Amiens

    Olivier GODEFROY, MD

    Not yet recruiting

  • CH Arras

    Arras

    Patrick LE COZ, MD

    Not yet recruiting

  • CH Beauvais

    Beauvais

    Xavier CNOCKAERT, MD

    Not yet recruiting

  • CH Béthune

    Béthune

    Isabelle LAVENU, MD

    Not yet recruiting

  • CHU Caen

    Caen

    Olivier MARTINAUD, MD

    Not yet recruiting

  • CH Calais

    Calais

    Olivier DEREEPER, MD

    Not yet recruiting

  • CH Dunkerque

    Dunkirk

    Abdelghani EL AZOUZI, MD

    Not yet recruiting

  • CH Le Quesnoy

    Le Quesnoy

    Denis LEFEBVRE, MD

    Not yet recruiting

  • CH Lens

    Lens

    Olivier SENECHAL, MD

    Not yet recruiting

  • Hôpital Roger Salengro

    Lille, 59037

    Thibaut Lebouvier, MD

    Recruiting

  • CHU Lille consultation mémoire Les Bâteliers

    Lille

    Dominique HUVENT, MD

    Not yet recruiting

  • CH Roubaix

    Roubaix

    Pierre FORZY, MD

    Not yet recruiting

  • CHU Rouen

    Rouen

    David WALLON, MD

    Not yet recruiting

  • CH Saint Quentin

    Saint-Quentin

    Jadwiga ATTIER-ZMUDKA, MD

    Not yet recruiting

  • CH Seclin

    Seclin

    Véronique BERRIOT, MD

    Not yet recruiting

  • CH Tourcoing

    Tourcoing

    Karim GALLOUJ, MD

    Not yet recruiting

  • CH Valenciennes

    Valenciennes

    Anne DESPREZ, MD

    Not yet recruiting

Other trials in France

About this study

Official title: 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).

Being tested
Caffeine, Placebo
Keywords
Alzheimer's disease, caffeine, cognitive impairment
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaffeineDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT04570085
Study groupRoleWhat they receive
CaffeineExperimentalafter a 3 weeks up titration period, 1 capsule of 200 mg twice a day during 27 weeks (ie 400mg/day)
Receives: Drug: Caffeine
placeboPlacebo comparatorafter a 3 weeks up titration period, 2 capsules per day during 27 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in NTB scores

    difference between randomized value and value after 30 weeks of treatment

    Measured: 30 weeks after randomization

Secondary outcomes (23)

  1. Caffeine treatment effect on MMSE score

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

    Measured: 30 weeks after randomization

  2. Caffeine treatment effect on NTB subscores

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

    Measured: 30 weeks after randomization

  3. Caffeine treatment effect on TAP scores

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

    Measured: 30 weeks after randomization

  4. Caffeine treatment effect on Epworth score

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

    Measured: 30 weeks after randomization

  5. Caffeine treatment effect on DAD-6 score

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

    Measured: 30 weeks after randomization

  6. Caffeine treatment effect on QoL-AD score

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

    Measured: 30 weeks after randomization

  7. Caffeine treatment effect on CGIC score

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

    Measured: 30 weeks after randomization

  8. Caffeine treatment effect on Zarit score

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

    Measured: 30 weeks after randomization

  9. 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

    Measured: 36 weeks after randomization

  10. 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

    Measured: 36 weeks after randomization

  11. 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

    Measured: 36 weeks after randomization

  12. 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

    Measured: 36 weeks after randomization

  13. 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

    Measured: 36 weeks after randomization

  14. 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

    Measured: 36 weeks after randomization

  15. 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

    Measured: 36 weeks after randomization

  16. Caffeine effect heterogeneity: impact of AD treatment

    impact of AD treatment on caffeine effect

    Measured: 30 weeks after randomization

  17. Caffeine effect heterogeneity: impact of ApoE4 status

    impact of ApoE4 status on caffeine effect

    Measured: 30 weeks after randomization

  18. Caffeine effect heterogeneity: impact of caffeine metabolism speed

    impact of caffeine metabolism on caffeine effect

    Measured: 30 weeks after randomization

  19. Caffeine effect heterogeneity: impact of gender

    impact of gender on caffeine effect

    Measured: 30 weeks after randomization

  20. Caffeine safety profile: NPI scores

    changes in NPI scores and subscores between caffeine and placebo arms

    Measured: 30 weeks after randomization

  21. Caffeine safety profile: heart beat

    changes in heart beat between caffeine and placebo arms

    Measured: 30 weeks after randomization

  22. Caffeine safety profile: blood pressure

    changes in blood pressure between caffeine and placebo arms

    Measured: 30 weeks after randomization

  23. Caffeine and its derivatives concentrations in blood samples

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

    Measured: 30 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start1 Mar 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
248 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04570085
Sponsor's protocol ID
2018_95
Other IDs
2019-002360-27, 2019
Acronym
CAFCA
Status last verified
Mar 2026
First submitted
8 Jun 2020
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Caffeine in people with Alzheimer Disease, run by University Hospital, Lille at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thibaud LEBOUVIER, MD,PhD (03 20 44 60 21 ext. +33, thibaud.lebouvier@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in NTB scores (time frame: 30 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04570085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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