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

Primary Purpose

Alzheimer Disease, Memory Disorders

Status

Not yet recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Recording of smartphone usage data

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer Disease, Smartphone, Memory Disorders

Eligibility Criteria

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

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

Sites / Locations

CHU Poitiers

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Memory complaint

Mild cognitive decline

Alzheimer's Disease

Arm Description

Outcomes

Primary Outcome Measures

Comparison of a mathematical combination

The comparison of a mathematical combination of the different parameters collected during the three months of smartphone data recording

Secondary Outcome Measures

Full Information

NCT ID

NCT05709210

First Posted

January 24, 2023

Last Updated

July 13, 2023

Sponsor

Poitiers University Hospital

Collaborators

University of Poitiers

1. Study Identification

Unique Protocol Identification Number

NCT05709210

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 20, 2023 (Anticipated)

Primary Completion Date

July 20, 2023 (Anticipated)

Study Completion Date

February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

Collaborators

University of Poitiers

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Memory Disorders

Keywords

Alzheimer Disease, Smartphone, Memory Disorders

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Memory complaint

Arm Type

Other

Arm Title

Mild cognitive decline

Arm Type

Other

Arm Title

Alzheimer's Disease

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Recording of smartphone usage data

Intervention Description

Recording of smartphone usage data

Primary Outcome Measure Information:

Title

Comparison of a mathematical combination

Description

The comparison of a mathematical combination of the different parameters collected during the three months of smartphone data recording

Time Frame

Up to three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

IMZI Nadia

Phone

+33(0)549444444

n.imzi@chu-poitiers.fr

First Name & Middle Initial & Last Name or Official Title & Degree

RABOIS Emilie

Phone

+33(0)549444444

e.rabois@chu-poitiers.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JULIAN Adrien

Organizational Affiliation

Poitiers University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Poitiers

City

Poitiers

ZIP/Postal Code

86000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

IMZI Nadia

Phone

+33(0)549444444

n.imzi@chu-poitiers.fr

First Name & Middle Initial & Last Name & Degree

RABOIS Emilie

Phone

+33(0)549444444

e.rabois@chu-poitiers.fr

First Name & Middle Initial & Last Name & Degree

JULIAN Adrien, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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