NCT05642351

Brief Summary

Autobiographical memory is diminished in patients with Alzheimer's Disease and those with behavioral variant of frontotemporal dementia, and research has focused on the hampered ability of patients in retrieving specific memories. However, this study proposes a detailed methodology to provide a qualitative analysis of autobiographical specificity.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 22, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 3, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

November 22, 2022

Last Update Submit

September 12, 2024

Conditions

Keywords

Autobiographical memoryAlzheimer's diseasewith behavioral variant of frontotemporal dementia

Outcome Measures

Primary Outcomes (1)

  • Autobiographical specificity

    We will apply the method by Raes et al. (2007) to assess whether each retrieved event refers to a: specific event, categorical event, extended event, or semantic event

    40 minutes

Study Arms (2)

Alzheimer's Disease

recruited according to criteria by National Institute on Aging (McKhann et al., 2011).

Other: Autobiographical reminder

Behavioral variant of frontotemporal dementia

recruited following criteria by Rascovsky et al. (2011)

Other: Autobiographical reminder

Interventions

The analysis of the specificity of Autobiographical Recall will be done through the following scale, developed for the study: * 6 points for a recall involving a single personal event located in space AND time (e.g.,"I remember when my parents took me to the sea for the first time..in 1962..in Dunkerque") * 5 points for a recall involving a single personal event located in space OR time ("I remember when my parents first took me to the sea...in 1962") * 4 points for a recall involving a single personal event but without spatial/temporal details ("I remember when my parents took me to the sea for the first time") * 3 points for a recall involving a general personal event but located in space AND time ("we used to go to Dunkerque in the summer") * 2 points for a recall involving a general personal event but located in space OR time ("we used to go to Dunkerque") * 1 point for a recall involving a general personal event without spatial/temporal details ("we used to go on vacation")

Alzheimer's DiseaseBehavioral variant of frontotemporal dementia

Eligibility Criteria

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

All participants will be recruited through the active file of memory consultations of the "memory resource and research center" (CMRR) of the Nantes University Hospital.

You may qualify if:

  • Alzheimer' disease or avioral variant of frontotemporal dementia
  • No opposition from the patient to be included in the study
  • For Alzheimer's patients: a score of more than 24 out of 30 on the Mini Mental State Examination (McKhann et al., 1984)

You may not qualify if:

  • Other psychiatric/neurological disorders
  • Minor patients
  • Adults under guardianship or protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EL HAJ Mohamad

Nantes, France

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseFrontotemporal Dementia

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 8, 2022

Study Start

February 3, 2023

Primary Completion

December 3, 2025

Study Completion

December 3, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations