Cognitive ImpairmentMemScreenNCT03811184
Validation of a Smartphone Application for the Assessment of Patients With Mild Cognitive Impairment: MemScreen
An observational study of Cognitive Impairment and Alzheimer Disease, run by MemScreen at 1 site in France.
Trial summary
The clinical evaluation of a patient with a cognitive complaint requires neuropsychological tests, evaluating the integrity of memory and other cognitive functions. The initial evaluation is made most often by a doctor (general practitioner). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Alzheimer Disease
- What is being tested?
- MemScreen
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2019to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population seen on memory clinic for memory complaints.
Who may be able to join
- Major patients followed in memory clinic.
- Performing a neuropsychological assessment less than 6 months old.
- No visual or motor deficiency impeding the use of a digital tablet.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Neurologie Cognitive Hôpital Fernand Widal
Paris, 75010
Julien Dumurgier, MD, 0033140054313, julien.dumurgier@aphp.fr
About this study
The clinical evaluation of a patient with a cognitive complaint requires neuropsychological tests, evaluating the integrity of memory and other cognitive functions.
The initial evaluation is made most often by a doctor (general practitioner). In case of need for further examination, a neuropsychological report is made in consultation memory by a neuropsychologist, with further cognitive tests.
The Cognitive Neurology Center at Lariboisière Hospital - Fernand Widal has developed a tool on a digital tablet or smartphone to evaluate cognitive functions: MemScreen.
The purpose of this study is to validate this new neuropsychological test on tablet compared to the neuropsychological reference tests.
Read the detailed description
Characteristics of MemScreen :
- Smartphone / tablet application developed by the Cognitive Neurology Center at Lariboisière - Fernand Widal Hospital to explore a patient with a cognitive disorder.
- The application is a self-test by the patient under the supervision of a doctor.
- The doctor has an account to be able to pass the test to patients.
- The tablet test is anonymous without the possibility to identify the patient.
- Conditions
- Cognitive Impairment, Alzheimer Disease
- Being tested
- MemScreen
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemScreenDiagnostic test
Neuropsychological test on smartphone or digital tablet, on self assesment.
| Study group | Role | What they receive |
|---|---|---|
| MemScreen | Each participants will undergo MemScreen : a screening tool on smartphone for detecting mild cognitive impairment. Receives: Diagnostic Test: MemScreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to detect patients with mild cognitive impairment.
To evaluate the ability of MemScreen to discriminate patients with an objective memory disorder from a validated neuropsychological reference test: the free and cued selective reminding test.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start17 Jan 2019
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MemScreen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien Dumurgier, MD, Principal investigator, Cognitive Neurology Center of Lariboisiere Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811184
- Sponsor's protocol ID
- 2018-A02672-53
- Acronym
- MemScreen
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Smartphone Application for the Assessment of Patients With Mild Cognitive Impairment: MemScreen
- ClinicalTrials.gov ID
- NCT03811184
- Acronym / sponsor ID
- MemScreen / 2018-A02672-53
- Conditions
- Cognitive Impairment, Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- MemScreenIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical evaluation of a patient with a cognitive complaint requires neuropsychological tests, evaluating the integrity of memory and other cognitive functions.
The initial evaluation is made most often by a doctor (general practitioner). In case of need for further examination, a neuropsychological report is made in consultation memory by a neuropsychologist, with further cognitive tests.
The Cognitive Neurology Center at Lariboisière Hospital - Fernand Widal has developed a tool on a digital tablet or smartphone to evaluate cognitive functions: MemScreen.
The purpose of this study is to validate this new neuropsychological test on tablet compared to the neuropsychological reference tests.
Detailed description
Characteristics of MemScreen :
- Smartphone / tablet application developed by the Cognitive Neurology Center at Lariboisière - Fernand Widal Hospital to explore a patient with a cognitive disorder.
- The application is a self-test by the patient under the supervision of a doctor.
- The doctor has an account to be able to pass the test to patients.
- The tablet test is anonymous without the possibility to identify the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MemScreen | – | Diagnostic Test: MemScreenEach participants will undergo MemScreen : a screening tool on smartphone for detecting mild cognitive impairment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population seen on memory clinic for memory complaints.
Key inclusion criteria (3 listed)
- Major patients followed in memory clinic.
- Performing a neuropsychological assessment less than 6 months old.
- No visual or motor deficiency impeding the use of a digital tablet.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemScreenNeuropsychological test on smartphone or digital tablet, on self assesment. | Diagnostic test | MemScreen |
Primary outcome
Ability to detect patients with mild cognitive impairment.
Time frame: through study completion, an average of 6 months
To evaluate the ability of MemScreen to discriminate patients with an objective memory disorder from a validated neuropsychological reference test: the free and cued selective reminding test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Dumurgier, MD principal investigator
Cognitive Neurology Center of Lariboisiere Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Alzheimer Disease, run by MemScreen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Dumurgier, MD (0033140054313, julien.dumurgier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to detect patients with mild cognitive impairment. (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.