Pilot Study on the Feasibility of Using Smartphone Data as a Diagnostic Marker for Alzheimer's Disease.

NCT ID: NCT05709210

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-27

Study Completion Date

2024-02-15

Brief Summary

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This study will compare smartphone usage data between three groups of patients diagnosed with either a memory complaint, mild cognitive decline, or Alzheimer's disease.

Detailed Description

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Alzheimer's disease (AD) is the leading cause of dementia in the world. The first cognitive function affected is memory and then other cognitive systems are affected leading to a progressive loss of autonomy of the patient. Currently, the diagnosis of AD is made at too late a stage. Patients with memory complaints or mild cognitive decline (MCI) are particularly at risk of developing AD.

However, there is no clinical or paraclinical evidence to predict precisely this risk of progression to AD. Investigator's hypothesis is that there is an association between the evolution of smartphone use and the conversion of cognitive status to AD.

The purpose of this pilot study is to identify existing differences between smartphone use data of patients with a memory complaint or of patients MCI or with an AD. It is a study of 90 patients (30 patients with memory complaint, 30 with MCI and 30 with AD) with a collection of smartphone usage data during three months.

Conditions

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Alzheimer Disease Memory Disorders

Keywords

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Alzheimer Disease Smartphone Memory Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Memory complaint

Group Type OTHER

Recording of smartphone usage data

Intervention Type OTHER

Recording of smartphone usage data

Mild cognitive decline

Group Type OTHER

Recording of smartphone usage data

Intervention Type OTHER

Recording of smartphone usage data

Alzheimer's Disease

Group Type OTHER

Recording of smartphone usage data

Intervention Type OTHER

Recording of smartphone usage data

Interventions

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Recording of smartphone usage data

Recording of smartphone usage data

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient consulting in routine care in one of the CMRR
* No sensory impairment that may compromise smartphone use

Exclusion Criteria

* Inability to perform MMSE or MMSE \< 20 ;
* Other neurodegenerative condition (Parkinson's disease, Lewy body disease, frontotemporal lobar degeneration, amyotrophic lateral sclerosis)
* Severe anxiety or depressive disorder HADS score ≥ 17
* Terminal phase of a severe disease
* Evidence of a lesion on MRI that may be involved in cognitive impairment
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Poitiers

OTHER

Sponsor Role collaborator

Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Adrien JULIAN

Role: CONTACT

Phone: +33(0)549444444

Email: [email protected]

RABOIS Emilie

Role: CONTACT

Phone: +33(0)549444444

Email: [email protected]

Facility Contacts

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IMZI Nadia

Role: primary

RABOIS Emilie

Role: backup

Other Identifiers

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IMASMART

Identifier Type: -

Identifier Source: org_study_id