- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05709210
Pilot Study on the Feasibility of Using Smartphone Data as a Diagnostic Marker for Alzheimer's Disease (IMASMART)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adrien JULIAN
- Phone Number: +33(0)549444444
- Email: adrien.julian@chu-poitiers.fr
Study Locations
-
-
-
Poitiers, France, 86000
- Recruiting
- CHU Poitiers
-
Principal Investigator:
- JULIAN Adrien, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Alzheimer's Disease
|
Recording of smartphone usage data
|
|
Other: Memory complaint
|
Recording of smartphone usage data
|
|
Other: Mild cognitive decline
|
Recording of smartphone usage data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of a mathematical combination
Time Frame: Up to three months
|
The comparison of a mathematical combination of the different parameters collected during the three months of smartphone data recording
|
Up to three months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: JULIAN Adrien, Poitiers University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dementia
- Tauopathies
- Neurodegenerative Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Alzheimer Disease
- Memory Disorders
Other Study ID Numbers
- 2021-A00615-36
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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