NCT05516667

Brief Summary

This is the pilot phase of a longitudinal observational cohort study. The study includes family clusters comprised of a patient with Alzheimer's disease, an informal caregiver and at least one first-degree relative of the patient. The family clusters will be followed-up in expert memory centers and online in order to study risk and prognostic factors (including blood-based biomarkers) in the first-degree relatives and patients, respectively, as well as caregiver health, difficulties and needs. This pilot study is performed to assess the feasibility of conducting a larger-scale study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Apr 2023Jan 2027

First Submitted

Initial submission to the registry

August 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

April 6, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

3.2 years

First QC Date

August 23, 2022

Last Update Submit

December 16, 2024

Conditions

Alzheimer Disease

Keywords

dementiacaregiversrisk factorsprognosisfirst-degree relatives

Outcome Measures

Primary Outcomes (2)

  • Recruitment rate

    rate of actual inclusion on anticipated inclusion 9 months and 18-months after the first inclusion. Expressed in percentage

    18-months after the first inclusion

  • Retention rate

    rate of remaining participants on actual inclusions 24 months after the first subject was included. Expressed in percentage

    24 months after the first inclusion

Secondary Outcomes (1)

  • Cognitive function

    60 months after Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

3 types of participants : patients with AD, caregivers assisting such patients on daily activities, and close relatives as defined above

You may qualify if:

  • AD patients:
  • Probable Alzheimer's disease (clinical and biological NINCDS-ADRDA 2011 criteria)
  • Mild-moderate AD (MMSE ≥15)
  • Sufficiently fluent in French in order to answer study questionnaires
  • Agrees to undergo medical examinations at baseline, 12 and 24 months, as outlined in the protocol
  • Affiliated to French social security
  • Written informed consent
  • Caregivers:
  • Caregiver (defined as assisting the patient in activities of daily living for at least 6 hours per week during the last 6 months) to an AD patient having agreed to participate in the study
  • Age ≥18 years.
  • Sufficiently fluent in French in order to answer study questionnaires
  • Agrees to answer regular questionnaires about their own or the AD patient's health (during visits at study centres or via a secure internet website/postal questionnaires)
  • Affiliated to French social security
  • Written informed consent
  • First-degree relatives:
  • +9 more criteria

You may not qualify if:

  • AD patients:
  • Other brain disorders
  • Autosomal dominant form of AD
  • Under legal protection measure (guardianship, curators, safeguard of justice…)
  • Institutionalized
  • Life expectancy \<2 years
  • Caregivers:
  • Under legal protection measure (guardianship, curators, safeguard of justice…)
  • Diagnosed with a major neurocognitive disorder
  • First-degree relatives:
  • Related to a patient with an autosomal dominant form of dementia
  • Carrier of an autosomal dominant dementia mutation
  • Under legal protection measure (guardianship, curators, safeguard of justice…)
  • Diagnosed with a major neurocognitive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpitaux Universitaires de Marseille Timone

France, Marseille, 13005, France

RECRUITING

CMRR Centre de Montpellier

Montpellier, France

RECRUITING

CMRR Centre de Rouen

Rouen, France

RECRUITING

CMRR - CRC Centre de Toulouse

Toulouse, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Sandrine Andrieu, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine Andrieu, MD PhD

CONTACT

05 61 14 59 63sandrine.andrieu@univ-tlse3.fr

Nicola Coley, PhD

CONTACT

coley.n@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 25, 2022

Study Start

April 6, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations

FR(4)