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

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Caffeine
Placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, caffeine, cognitive impairment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens
  • CH Arras
  • CH Beauvais
  • CH Béthune
  • CHU Caen
  • CH Calais
  • CH Dunkerque
  • CH Le Quesnoy
  • CH Lens
  • Hôpital Roger SalengroRecruiting
  • CHU Lille consultation mémoire Les Bâteliers
  • CH Roubaix
  • CHU Rouen
  • CH Saint Quentin
  • CH Seclin
  • CH Tourcoing
  • CH Valenciennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caffeine

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in NTB scores
difference between randomized value and value after 30 weeks of treatment

Secondary Outcome Measures

Caffeine treatment effect on MMSE score
difference between randomized value and value after 30 weeks of treatment on MMSE score
Caffeine treatment effect on NTB subscores
difference between randomized value and value after 30 weeks of treatment on NTB subscores
Caffeine treatment effect on TAP scores
difference between randomized value and value after 30 weeks of treatment on TAP scores
Caffeine treatment effect on Epworth score
difference between randomized value and value after 30 weeks of treatment on Epworth score
Caffeine treatment effect on DAD-6 score
difference between randomized value and value after 30 weeks of treatment on DAD-6 score
Caffeine treatment effect on QoL-AD score
difference between randomized value and value after 30 weeks of treatment on QoL-AD score
Caffeine treatment effect on CGIC score
difference between randomized value and value after 30 weeks of treatment on CGIC score
Caffeine treatment effect on Zarit score
difference between randomized value and value after 30 weeks of treatment on Zarit score
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
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
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
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
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
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
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
Caffeine effect heterogeneity: impact of AD treatment
impact of AD treatment on caffeine effect
Caffeine effect heterogeneity: impact of ApoE4 status
impact of ApoE4 status on caffeine effect
Caffeine effect heterogeneity: impact of caffeine metabolism speed
impact of caffeine metabolism on caffeine effect
Caffeine effect heterogeneity: impact of gender
impact of gender on caffeine effect
Caffeine safety profile: NPI scores
changes in NPI scores and subscores between caffeine and placebo arms
Caffeine safety profile: heart beat
changes in heart beat between caffeine and placebo arms
Caffeine safety profile: blood pressure
changes in blood pressure between caffeine and placebo arms
Caffeine and its derivatives concentrations in blood samples
increase in caffeinemia and its derivatives in the morning (fasting samples)

Full Information

First Posted
June 8, 2020
Last Updated
February 10, 2022
Sponsor
University Hospital, Lille
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation, Laboratory of excellence DISTALZ, Région Nord-Pas de Calais, France, Meo coffee
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1. Study Identification

Unique Protocol Identification Number
NCT04570085
Brief Title
Effect of CAFfeine on Cognition in Alzheimer's Disease
Acronym
CAFCA
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation, Laboratory of excellence DISTALZ, Région Nord-Pas de Calais, France, Meo coffee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's disease, caffeine, cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caffeine
Arm Type
Experimental
Arm Description
after a 3 weeks up titration period, 1 capsule of 200 mg twice a day during 27 weeks (ie 400mg/day)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
after a 3 weeks up titration period, 2 capsules per day during 27 weeks
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in NTB scores
Description
difference between randomized value and value after 30 weeks of treatment
Time Frame
30 weeks after randomization
Secondary Outcome Measure Information:
Title
Caffeine treatment effect on MMSE score
Description
difference between randomized value and value after 30 weeks of treatment on MMSE score
Time Frame
30 weeks after randomization
Title
Caffeine treatment effect on NTB subscores
Description
difference between randomized value and value after 30 weeks of treatment on NTB subscores
Time Frame
30 weeks after randomization
Title
Caffeine treatment effect on TAP scores
Description
difference between randomized value and value after 30 weeks of treatment on TAP scores
Time Frame
30 weeks after randomization
Title
Caffeine treatment effect on Epworth score
Description
difference between randomized value and value after 30 weeks of treatment on Epworth score
Time Frame
30 weeks after randomization
Title
Caffeine treatment effect on DAD-6 score
Description
difference between randomized value and value after 30 weeks of treatment on DAD-6 score
Time Frame
30 weeks after randomization
Title
Caffeine treatment effect on QoL-AD score
Description
difference between randomized value and value after 30 weeks of treatment on QoL-AD score
Time Frame
30 weeks after randomization
Title
Caffeine treatment effect on CGIC score
Description
difference between randomized value and value after 30 weeks of treatment on CGIC score
Time Frame
30 weeks after randomization
Title
Caffeine treatment effect on Zarit score
Description
difference between randomized value and value after 30 weeks of treatment on Zarit score
Time Frame
30 weeks after randomization
Title
persistent effect of caffeine treatment on MMSE score after a 6 weeks wash out period
Description
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
Time Frame
36 weeks after randomization
Title
persistent effect of caffeine treatment on NTB subscores after a 6 weeks wash out period
Description
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
Time Frame
36 weeks after randomization
Title
persistent effect of caffeine treatment on TAP scores after a 6 weeks wash out period
Description
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
Time Frame
36 weeks after randomization
Title
persistent effect of caffeine treatment on Epworth score after a 6 weeks wash out period
Description
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
Time Frame
36 weeks after randomization
Title
persistent effect of caffeine treatment on DAD-6 score after a 6 weeks wash out period
Description
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
Time Frame
36 weeks after randomization
Title
persistent effect of caffeine treatment on QoL-AD score after a 6 weeks wash out period
Description
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
Time Frame
36 weeks after randomization
Title
persistent effect of caffeine treatment on Zarit score after a 6 weeks wash out period
Description
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
Time Frame
36 weeks after randomization
Title
Caffeine effect heterogeneity: impact of AD treatment
Description
impact of AD treatment on caffeine effect
Time Frame
30 weeks after randomization
Title
Caffeine effect heterogeneity: impact of ApoE4 status
Description
impact of ApoE4 status on caffeine effect
Time Frame
30 weeks after randomization
Title
Caffeine effect heterogeneity: impact of caffeine metabolism speed
Description
impact of caffeine metabolism on caffeine effect
Time Frame
30 weeks after randomization
Title
Caffeine effect heterogeneity: impact of gender
Description
impact of gender on caffeine effect
Time Frame
30 weeks after randomization
Title
Caffeine safety profile: NPI scores
Description
changes in NPI scores and subscores between caffeine and placebo arms
Time Frame
30 weeks after randomization
Title
Caffeine safety profile: heart beat
Description
changes in heart beat between caffeine and placebo arms
Time Frame
30 weeks after randomization
Title
Caffeine safety profile: blood pressure
Description
changes in blood pressure between caffeine and placebo arms
Time Frame
30 weeks after randomization
Title
Caffeine and its derivatives concentrations in blood samples
Description
increase in caffeinemia and its derivatives in the morning (fasting samples)
Time Frame
30 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thibaud LEBOUVIER, MD,PhD
Phone
03 20 44 60 21
Ext
+33
Email
thibaud.lebouvier@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
thibaud LEBOUVIER, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier GODEFROY, MD
Facility Name
CH Arras
City
Arras
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LE COZ, MD
Facility Name
CH Beauvais
City
Beauvais
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier CNOCKAERT, MD
Facility Name
CH Béthune
City
Béthune
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle LAVENU, MD
Facility Name
CHU Caen
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MARTINAUD, MD
Facility Name
CH Calais
City
Calais
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier DEREEPER, MD
Facility Name
CH Dunkerque
City
Dunkerque
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelghani EL AZOUZI, MD
Facility Name
CH Le Quesnoy
City
Le Quesnoy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis LEFEBVRE, MD
Facility Name
CH Lens
City
Lens
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier SENECHAL, MD
Facility Name
Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaut Lebouvier, MD
Facility Name
CHU Lille consultation mémoire Les Bâteliers
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique HUVENT, MD
Facility Name
CH Roubaix
City
Roubaix
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre FORZY, MD
Facility Name
CHU Rouen
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David WALLON, MD
Facility Name
CH Saint Quentin
City
Saint-Quentin
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jadwiga ATTIER-ZMUDKA, MD
Facility Name
CH Seclin
City
Seclin
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique BERRIOT, MD
Facility Name
CH Tourcoing
City
Tourcoing
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim GALLOUJ, MD
Facility Name
CH Valenciennes
City
Valenciennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DESPREZ, MD

12. IPD Sharing Statement

Learn more about this trial

Effect of CAFfeine on Cognition in Alzheimer's Disease

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