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CAFCA

RecruitingPhase 3

Effect of CAFfeine on Cognition in Alzheimer's Disease

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

Asset

Caffeine

Listed sites

17

Recruiting sites

1

Enrollment

248

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE ≥16

Primary endpoint

•Changes in NTB scores

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2018_95
Eudract number2019-002360-27
NCT IDNCT04570085

Timeline

Milestones

Study first posted2020-09-30actual
Study start2021-03-01actual
Last update posted2026-04-20actual
Primary completion2027-12estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Drug assets

Caffeine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
13
Caregiver / quality of life
4
Global cognition
2
Function / daily living
2
Safety / tolerability / PK
2
Behavior / neuropsychiatric
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Caffeine treatment effect on MMSE score

Time frame:30 weeks after randomization

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

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

Time frame:36 weeks after randomization

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

2 endpoints
Secondary/protocol endpoint

Caffeine treatment effect on DAD-6 score

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint

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

Time frame:36 weeks after randomization

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Caffeine safety profile: NPI scores

Time frame:30 weeks after randomization

Neuropsychiatric Inventory (NPI)

descriptive

Caregiver / quality of life

4 endpoints
Secondary/protocol endpoint

Caffeine treatment effect on QoL-AD score

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint

Caffeine treatment effect on Zarit score

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint

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

Time frame:36 weeks after randomization

descriptive

Secondary/protocol endpoint

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

Time frame:36 weeks after randomization

descriptive

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Caffeine safety profile: heart beat

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint

Caffeine safety profile: blood pressure

Time frame:30 weeks after randomization

descriptive

Other (unclassified)

13 endpoints
Primary/protocol endpoint/low confidence

Changes in NTB scores

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

Caffeine treatment effect on NTB subscores

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

Caffeine treatment effect on TAP scores

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

Caffeine treatment effect on Epworth score

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

Caffeine treatment effect on CGIC score

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:36 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:36 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:36 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

Caffeine effect heterogeneity: impact of AD treatment

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

Caffeine effect heterogeneity: impact of ApoE4 status

Time frame:30 weeks after randomization

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Caffeine effect heterogeneity: impact of caffeine metabolism speed

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

Caffeine effect heterogeneity: impact of gender

Time frame:30 weeks after randomization

descriptive

Secondary/protocol endpoint/low confidence

Caffeine and its derivatives concentrations in blood samples

Time frame:30 weeks after randomization

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.