Subjective cognitive decline, early Alzheimer's Disease Nervous System Diseases
Conditions
Interventions
This is a prospective pilot study to assess the feasibility of conducting smartphone-based remote self-assessments of cognition, function and behavior in participants with SCD (subjective cognitive de
a 30-day smartphone-based remote self-assessment period
and an end-of study visit at the clinic.
It is planned to recruit 60 SCD, 30 eAD participants, and 30 healthy controls.
Screening visit:
The following
Parts A & B)
• Category Fluency Test (Animals)
• Digit Symbol Coding Test
• Boston Naming Test
• Amsterdam instrumental activities of da
Sponsors
Roche (United States)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence level defined as the fraction of days the participants have completed the digital assessments during the observation period of 30 days measured using the smartphone software | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensor data (movement and location data) collected using smartphone sensor metrics throughout the duration of the study 2. Vital signs measured by the researcher at baseline and end of study/termination visit 3. Social network measured using the Social Network Index (SNI) at baseline and end of study/termination visit 4. Loneliness measured using the revised University of California, Los Angeles (UCLA) Loneliness Scale at baseline and end of study/termination visit 5. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and end of study/termination visit 6. Gait and balance (Timed 25-foot walk test [T25WT] and Timed Up and Go [TUG] test) at baseline and end of study/termination visit 7. Brain imaging (MRI) at baseline and end of study/termination visit 8. Adverse events measured by self-report at end of study/termination visit | — |
Countries
Spain, United States of America
Outcome results
None listed