NCT04570085

Brief 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 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P25-P50 for phase_3 alzheimer-disease

Timeline
19mo left

Started Mar 2021

Longer than P75 for phase_3 alzheimer-disease

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Mar 2021Dec 2027

First Submitted

Initial submission to the registry

June 8, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 20, 2026

Status Verified

March 1, 2026

Enrollment Period

6.8 years

First QC Date

June 8, 2020

Last Update Submit

April 17, 2026

Conditions

Alzheimer Disease

Keywords

Alzheimer's diseasecaffeinecognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Changes in NTB scores

    difference between randomized value and value after 30 weeks of treatment

    30 weeks after randomization

Secondary Outcomes (23)

  • Caffeine treatment effect on MMSE score

    30 weeks after randomization

  • Caffeine treatment effect on NTB subscores

    30 weeks after randomization

  • Caffeine treatment effect on TAP scores

    30 weeks after randomization

  • Caffeine treatment effect on Epworth score

    30 weeks after randomization

  • Caffeine treatment effect on DAD-6 score

    30 weeks after randomization

  • +18 more secondary outcomes

Study Arms (2)

Caffeine

EXPERIMENTAL

after a 3 weeks up titration period, 1 capsule of 200 mg twice a day during 27 weeks (ie 400mg/day)

Drug: Caffeine

placebo

PLACEBO COMPARATOR

after a 3 weeks up titration period, 2 capsules per day during 27 weeks

Drug: Placebo

Interventions

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.

Caffeine
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.

placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 :
  • Chronic use of CYP1A2 inducing or inhibiting drugs
  • All caffeine-containing specialties
  • Drugs that influence caffeine metabolism
  • Drugs that may interact with caffeine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

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

CH Calais

Calais, France

NOT YET RECRUITING

CH Dunkerque

Dunkirk, France

NOT YET RECRUITING

CH Le Quesnoy

Le Quesnoy, France

NOT YET RECRUITING

CH Lens

Lens, France

NOT YET RECRUITING

Hôpital Roger Salengro

Lille, 59037, France

RECRUITING

CHU Lille consultation mémoire Les Bâteliers

Lille, France

NOT YET RECRUITING

CH Roubaix

Roubaix, France

NOT YET RECRUITING

CHU Rouen

Rouen, France

NOT YET RECRUITING

CH Saint Quentin

Saint-Quentin, France

NOT YET RECRUITING

CH Seclin

Seclin, France

NOT YET RECRUITING

CH Tourcoing

Tourcoing, France

NOT YET RECRUITING

CH Valenciennes

Valenciennes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

Caffeine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • thibaud LEBOUVIER, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thibaud LEBOUVIER, MD,PhD

CONTACT

03 20 44 60 21thibaud.lebouvier@chru-lille.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

September 30, 2020

Study Start

March 1, 2021

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 20, 2026

Record last verified: 2026-03

Locations

FR(17)