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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709210
• Other study ID #: IMASMART
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: December 2023
• Source: Poitiers University Hospital
• Contact: Adrien JULIAN
• Phone: +33(0)549444444
• Email: adrien.julian[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Memory Disorders

Intervention

Other:
• Recording of smartphone usage data
Recording of smartphone usage data

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	University of Poitiers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of a mathematical combination	The comparison of a mathematical combination of the different parameters collected during the three months of smartphone data recording	Up to three months