Using digital devices to improve assessments for early Alzheimer's disease
Digital Evaluations and Technologies Enabling Clinical Translation for AD
This study is testing whether using digital devices at home can help track daily activities and changes in people at risk for early Alzheimer's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05385913 on ClinicalTrials.gov |
What this trial studies
The DETECT-AD study aims to enhance clinical trial assessments for early Alzheimer's disease by utilizing home-based digital devices that monitor various aspects of daily life. Participants will undergo a brain scan to evaluate their risk for developing Alzheimer's and will then have their homes equipped with devices that track mobility, cognition, sleep, and socialization over a 36-month period. This observational study will simulate a clinical trial environment to assess how effectively these digital tools can detect meaningful changes in participants' conditions. The data collected will help researchers understand the relationship between daily activities and cognitive function in individuals at risk for Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 65 or older who have a study partner and meet specific cognitive criteria.
Not a fit: Patients with advanced Alzheimer's disease or those who do not have access to the required technology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for monitoring and assessing early Alzheimer's disease, potentially enhancing future clinical trials.
How similar studies have performed: While the use of digital devices in clinical assessments is a growing field, this specific approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Sign the informed consent form to enrollment in the protocol 2. Have a study partner available to participate in this study 3. Be 65 or older 4. Living alone or with a cohabitant over age 18 (cohabitant will also be required to consent to the home technology and will be given the option to fully participate in home-based study activities) 5. Be willing to participate in genetic research 6. Ability to have an internet connection at home, financial support supplied by study. 7. Ability to complete surveys via email on a computer, or cell phone 8. In the opinion of the investigator, be of adequate physical health that participation in the research would not pose a significant risk to the health of the subject 9. Meets criteria for normative (not dementia) cognition, i.e., ≧ Bondi/Jak criteria for MCI 10. If taking an antidepressant, must be on stable dose for at least 12 weeks 11. Study partner is functionally independent and has a MMSE of 24-30, inclusive or Montreal Cognitive Assessment equivalent (adjusted for education, ethnic/racial circumstance). 12. Participant and study partner are computer literate, defined as able to send and receive an email 13. Household has and uses a desktop, laptop, tablet, or smartphone 14. Lives in a residence composed of at least a living space and bathroom Exclusion Criteria: * 1. Significant neurologic disease such as AD, multi-infarct dementia, Parkinson's disease, normal pressure hydrocephalus, brain tumor, cortical infarct on MRI, or a history of significant head trauma with subsequent persistent neurologic deficits. 2. Major psychiatric disorder such as major depression, bipolar disorder (DSM-IV criteria), or history of schizophrenia (DSM-IV). Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol. 3. History of alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria). 4. Uncontrolled medical conditions precluding completion of the study, e.g., late-stage cancers. 5. Cannot undergo neuroimaging procedures (e.g., claustrophobia, metallic implants) 6. More than two people live in the participant's residence (overnight visitors are acceptable).
Where this trial is running
Portland, Oregon
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer L Marcoe, MA
- Email: marcoej@ohsu.edu
- Phone: 5034941329
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.