A prospective pilot study to evaluate the feasibility of conducting smartphone-based remote self-assessments of cognition, function, and behavior in individuals with subjective cognitive decline, early Alzheimer's disease, and healthy controls

Roche (United States)0 sites120 target enrollmentNovember 10, 2020

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Roche (United States)
Enrollment: 120
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2022 Abstract results in https://doi.org/10.14283/jpad.2022.97 P150, P152, P153, P209 (added 03/01/2024)

Registry

who.int

Start Date

November 10, 2020

End Date

October 16, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Roche (United States)

Eligibility Criteria

Inclusion Criteria

•1\. Signed informed consent form
•2\. Age 65 years or above
•3\. Previous experience with smartphone or tablet technology
•4\. Fluency in the language of the tests used at the study site
•5\. Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing
•6\. Willingness and ability to complete all aspects of the study (including brain MRI and PET imaging \[if applicable])
•7\. Availability of a study partner throughout the study and which agrees to provide information and to complete all aspects of the study at clinic visits

Exclusion Criteria

•1\. Unable to comply with the study protocol, in the investigator’s judgment
•2\. History or known presence of any significant neurological disorders such as Parkinson’s disease, multiple sclerosis, traumatic head injury, territorial infarct or brain tumor with cognitive sequelae
•3\. History or known presence of any significant psychiatric disorder such as schizophrenia, bipolar disorder, substance use disorders
•4\. Current active clinically significant anxiety or depressive disorder (moderate anxiety or depression as judged by the investigator) that is likely to impede a participant's ability to participate in the study
•5\. Current use of any medication that could affect cognitive performance (e.g. benzodiazepines, etc.)
•6\. Participation in any interventional AD clinical study including studies with digital assessments within the past 6 months at the time of screening
•7\. Any significant cerebral abnormalities or significant MRI finding such as ischemic or hemorrhagic strokes as confirmed by the central reader.
•8\. Inability to tolerate MRI procedures or contraindication to MRI, including but not limited to, presence of pacemakers not compatible with MRI, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan, or any other clinical history or examination finding that, in the judgment of the investigator, would pose a potential hazard in combination with MRI
•9\. In addition, for participants with SCD and healthy controls: Prior diagnosis and/or treatment for a memory disorder