An observational study in Alzheimer Disease, Early Onset, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Oregon Health and Science University · Observational
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
To achieve this objective, we propose the DETECT-AD (Digital Evaluations and Technologies Enabling Clinical Translation for AD) Study. DETECT-AD is a prospective trial simulation study using a current, extensible, sharable, technology agnostic, and home-based assessment platform that continuously generates DBs and metrics of everyday cognition and function (or Daily Indicators of Active Life - 'DIALS'). The platform also allows for remote capture of conventional clinical assessments as well. A simulated trial study design is used, as there are no current established therapies that will reliably improve meaningful function in stage 1-3 AD10 patients to a degree that one can directly test the sensitivity of DBs or DIALS to treatment mediated change. In short, if there is no change over time in the proposed measure, one would not know if it was a failure of the measure or the treatment. Hence, the use of the simulation paradigm. In this trial, participants with known CNS amyloid (Aβ) status (SUVR-based PET "positive" or "negative") will be enrolled. In the simulation, Aβ "positive" (higher amyloid burden) patients will predictably progress, as if they were receiving placebo; those with less amyloid (Aβ "negative") will have less progression, simulating effective treatment. Primary outcomes will be the change in DBs and DIALS composed of measures in 4 key domains: mobility, cognition, sleep, and socialization. Exploratory analyses of the relationship of the DBs with contemporary imaging (MRI) and blood-based biomarkers related to inflammation, neurodegeneration, vascular risk or injury, and nutritional health will also be conducted.
Impact: Successful completion of this study will provide foundational validated DB and DIALS data improving treatment response readout sensitivity, thus advancing AD clinical trial capability and capacity. The intent is to not only validate a single app or device, but to advance ecologically valid multi-domain assessment, as well as an entire trials-environment specific, DB-facilitated protocol that could be adapted and shared for use by any clinical trial or related study going forward.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
older adults living independenlty and/or with a partner; cognitively healthy and/or MCI; ages 65 or older
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.
Exclusion Criteria:
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.
AB high group; SUVR \>1.11
Other: Multivitamin-no intervention
AB low group; SUVR ≤1.11
Other: Multivitamin-no intervention
Each participant will also have a stud partner that will be enrolled.
No intervention. All participants will be given a multi-vitamin to take for the duration of the study
Rate of Progression of DB's
Determine rates of progression of DBs (of mobility, cognition, sleep, and social engagement) individually and as an aggregate metric (the DIALS) in stage 1-3 Aβ (+) vs. Aβ (-) participants. Early base rates (first months of monitoring) of progression, and then, longitudinal change will be established.
Time frame: 36 months
Utility of DB's
Establish the utility of these DBs compared to conventional measures used in trials (i.e., CDR-SoB, ADCS-PACC) by providing meaningful change readout earlier than conventional measures.
Time frame: 36 months
Investigate exploratory Aims
Investigate exploratory aims examining several high-value featurse of these DB's for application in trials and clinical studies: Correlate DBs and DIALS with conventional imaging and blood-based biomarkers; inflammation (interleukins, CRP), neurodegeneration (P-tau 181 and 231, NfL), vascular risk or injury (HbgA1C, MMP 1/2/3/9, ICAM, VCAM, VEGF) and nutritional health (oxylipins, homocysteine)
Time frame: 36 months
Change over time
Determine the change overtime of embedded cognitive clocks (time to complete regular weekly online report queries and monthly cognitive tests)
Time frame: 36 months
Establish adverse event fluctuations over time
(mood, illness, pain, ER, doctor, hospital visits, falls and injury, non-study medication changes) via weekly remote assessments
Time frame: 36 months
assess study partner
assess the study partners DB's change relative to the simulated treated study participant (mobility, sleep, social engagement)
Time frame: 36 months
Plan to share: Undecided
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Oregon Health and Science University