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
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer Disease, Smartphone, Memory Disorders
Eligibility Criteria
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
Other
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IMZI Nadia
Phone
+33(0)549444444
Email
n.imzi@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
RABOIS Emilie
Phone
+33(0)549444444
Email
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
Email
n.imzi@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
RABOIS Emilie
Phone
+33(0)549444444
Email
e.rabois@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
JULIAN Adrien, MD, PhD
12. IPD Sharing Statement
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Pilot Study on the Feasibility of Using Smartphone Data as a Diagnostic Marker for Alzheimer's Disease.
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