NCT02302482

Brief Summary

The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The investigators aimed at developing a database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative personal and with the University hospital computer science department. The main objective is to study the predictive factors associated with the change of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory Clinic. The study population would consist in about 1000 patients with ADRD. The length of follow-up of each patient will be 3 years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,860

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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 Progress89%
Nov 2014Nov 2027

Study Start

First participant enrolled

November 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

13 years

First QC Date

November 14, 2014

Last Update Submit

June 25, 2021

Conditions

Memory Impairment

Keywords

Alzheimer's disease or related disordersFunctional autonomy levelCognitive functionPredictive factors

Outcome Measures

Primary Outcomes (1)

  • Functional autonomy level

    The scores of "Lawton Instrumental Activities of Daily Living" (IADL) and of "Disability Assessment of Dementia" (DAD-6)

    3 years

Secondary Outcomes (1)

  • Cognitive function level

    3 years

Study Arms (1)

Functional autonomy level collection

EXPERIMENTAL

Collection of the Functional autonomy level every 6 - 12 months by phone

Other: The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6

Interventions

The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6OTHER
Functional autonomy level collection

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients who undergo a medical visit in the Memory Clinic for the 1st time
  • Patients living at home or in housing
  • Patients with memory impairment, at all stage of the disease

You may not qualify if:

  • Patients in institution
  • Patients under legal protection
  • Patients with a hearing or visual impairment, which dot not allow to carry out the examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Dugoujon

Caluire-et-Cuire, 69300, France

NOT YET RECRUITING

Hospices Civils de Lyon - Hôpital des Charpennes

Lyon, France

RECRUITING

Related Publications (1)

  • Dauphinot V, Moutet C, Rouch I, Verdurand M, Mouchoux C, Delphin-Combe F, Gaujard S, Krolak-Salmon P; MEMORA group. A multicenter cohort study to investigate the factors associated with functional autonomy change in patients with cognitive complaint or neurocognitive disorders: the MEMORA study protocol. BMC Geriatr. 2019 Jul 18;19(1):191. doi: 10.1186/s12877-019-1204-1.

    PMID: 31319809DERIVED

MeSH Terms

Conditions

Memory DisordersAlzheimer Disease

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Pierre Krolak-Salmon, Professor

CONTACT

(0)4 72 43 20 50pierre.krolak-salmon@chu-lyon.fr

Virginie Dauphinot, Doctor

CONTACT

(0)4 72 43 20 50virginie.dauphinot@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 27, 2014

Study Start

November 1, 2014

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

June 28, 2021

Record last verified: 2021-06

Locations

FR(2)