Alzheimer Disease, Early OnsetDETECT-ADNCT05385913
Digital Evaluations and Technologies Enabling Clinical Translation for AD
An observational study of Alzheimer Disease, Early Onset, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Early Onset
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: older adults living independenlty and/or with a partner; cognitively healthy and/or MCI; ages 65 or older
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Jennifer L Marcoe, MA, 503-494-1329, marcoej@ohsu.edu
Nicole Sharma, BS, 5034189328, sharmani@ohsu.edu
About this study
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.
Read more
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
Read the detailed description
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.
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- Multivitamin-no intervention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin-no interventionOther
No intervention. All participants will be given a multi-vitamin to take for the duration of the study
| Study group | Role | What they receive |
|---|---|---|
| "Placebo" | AB high group; SUVR >1.11 Receives: Other: Multivitamin-no intervention | |
| "Treatment" | AB low group; SUVR ≤1.11 Receives: Other: Multivitamin-no intervention | |
| Study Partners | Each participant will also have a stud partner that will be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 36 months
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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
Measured: 36 months
assess study partner
assess the study partners DB's change relative to the simulated treated study participant (mobility, sleep, social engagement)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Apr 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385913
- Sponsor's protocol ID
- STUDY00023803
- Other IDs
- 1R56AG074321-01
- Acronym
- DETECT-AD
- Status last verified
- Oct 2023
- First submitted
- 16 May 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Evaluations and Technologies Enabling Clinical Translation for AD
- ClinicalTrials.gov ID
- NCT05385913
- Acronym / sponsor ID
- DETECT-AD / STUDY00023803
- Conditions
- Alzheimer Disease, Early Onset
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Placebo" | – | Other: Multivitamin-no interventionAB high group; SUVR >1.11 |
| "Treatment" | – | Other: Multivitamin-no interventionAB low group; SUVR ≤1.11 |
| Study Partners | – | –Each participant will also have a stud partner that will be enrolled. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- older adults living independenlty and/or with a partner; cognitively healthy and/or MCI; ages 65 or older
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivitamin-no interventionNo intervention. All participants will be given a multi-vitamin to take for the duration of the study | Other | "Placebo", "Treatment" |
Primary outcome
Rate of Progression of DB's
Time frame: 36 months
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.
Utility of DB's
Time frame: 36 months
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.
4 secondary outcomes
Investigate exploratory Aims
Time frame: 36 months
Change over time
Time frame: 36 months
Establish adverse event fluctuations over time
Time frame: 36 months
assess study partner
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, Early Onset, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer L Marcoe, MA (5034941329, marcoej@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Progression of DB's (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.