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

Sponsor
Poitiers University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05709210
Collaborator
Xlim laboratory (Other)
90
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3
12.4
7.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: recording of smartphone usage data
N/A

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. Our 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pilot Study on the Feasibility of Using Smartphone Data as a Diagnostic Marker for Alzheimer's Disease.
Anticipated Study Start Date :
Feb 3, 2023
Anticipated Primary Completion Date :
Feb 15, 2023
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Memory complaint

Other: recording of smartphone usage data
recording of smartphone usage data

Other: mild cognitive decline

Other: recording of smartphone usage data
recording of smartphone usage data

Other: Alzheimer's Disease

Other: recording of smartphone usage data
recording of smartphone usage data

Outcome Measures

Primary Outcome Measures

  1. Comparison of a mathematical combination [up to three months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Poitiers Poitiers France 86000

Sponsors and Collaborators

  • Poitiers University Hospital
  • Xlim laboratory

Investigators

  • Principal Investigator: JULIAN Adrien, Poitiers University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT05709210
Other Study ID Numbers:
  • IMASMART
First Posted:
Feb 2, 2023
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Poitiers University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2023