Recruiting

Digital Evaluations

Sponsor:

Oregon Health and Science University

Code:

NCT05385913

Conditions

Alzheimer Disease, Early Onset

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Multivitamin-no intervention

Study Details

Brief summary:

The DETECT-AD study (stands for "Digital Evaluations and Technologies Enabling Clinical Translation for Alzheimer's Disease") is a new study designed to improve clinical trials for early Alzheimer's disease. DETECT-AD uses specialized home-based digital devices (electronic scale, electronic pill box, under-the-mattress sleep sensor, motion activity sensors, wrist watch activity tracker, driving sensor, and computer software) to see if the devices will improve clinical trial assessments. This 36- month-long study will simulate a clinical trial to determine how well the home system detects clinically meaningful changes. Participants in DETECT will receive a brain scan to assess their risk for developing Alzheimer's Disease.

After the scan, homes will be outfitted with the devices\*. Participants will be asked to simply go about their daily routines while data is collected in the background by the digital devices.

The scientists will see if there is a change in the digital assessments in four key areas of life activity:

mobility (walking speed), cognition (computer use), sleep (sleep times), and socialization (time spent out of home). Participants will be asked to take a daily multivitamin as a study 'drug' to mimic clinical trial conditions. Using these methods, the DETECT study will produce outcome measures that reflect real-world everyday function. Establishing the superiority of these novel methods compared to conventional methods (for example, exams in a clinic) will provide a potential new pathway for speeding the development of muchneeded new treatments for Alzheimer's

Conditions

Alzheimer Disease, Early Onset

Study ID

NCT05385913

Start date

Apr 1, 2022

Status verified date

Oct, 2023

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

"Placebo"

AB high group; SUVR >1.11

"Treatment"

AB low group; SUVR ≤1.11

Study Partners

Each participant will also have a stud partner that will be enrolled.

Interventions

Multivitamin-no intervention

No intervention. All participants will be given a multi-vitamin to take for the duration of the study

Primary outcome measure

  • Rate of Progression of DB's [ Time Frame: 36 months ]
  • Utility of DB's [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Jennifer L Marcoe, MA

5034941329marcoej@ohsu.edu

Nicole Sharma, BS

5034183928sharmani@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jennifer L Marcoe, MA

503-494-1329marcoej@ohsu.edu

Nicole Sharma, BS

5034189328sharmani@ohsu.edu

Principal Investigator:

Jeffrey Kaye, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Dec 6, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2023-12-06.