An observational study in Alzheimer Disease, Mild Cognitive Impairment and Mild Dementia, sponsored by Optina Diagnostics Inc.. Completed at 7 sites in 2 countries. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Optina Diagnostics Inc. · Observational
Among 1,939 studies in Alzheimer Disease with a site in United States — 345 open to participants now, 445 under way, 40 of them phase 3. Alzheimer Disease · United States.
Among the 1,939 studies in Alzheimer Disease with a site in United States, this one is the 98th largest by enrollment of the 309 observational ones that give a count, is one of 131 that started in 2022, is one of 310 observational ones, and was the 1,379th registered.
3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →345 of the 1,939 studies in Alzheimer Disease with a site in United States are open now. Recruiting first, the newest first:
National Institute on Aging (NIA) · Sites in United States
Ages 55–110 · Healthy volunteers
National Institute on Aging (NIA) · Sites in United States
Ages 65–120 · Healthy volunteers
Prevention Research Consortium Corp. · Sites in United States
Ages 55+ · Healthy volunteers
Hoffmann-La Roche · Sites in United States, Australia, France
Ages 50–90
University of Wisconsin, Madison · Sites in United States
Ages 60+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.
This study: 50 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,939 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 371 · Phase 2 469 · Phase 3 230 · Phase 4 60
First in 1981; this study’s year is marked. 131 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 466 is above the median of 200 across 815 observational studies indexed under Alzheimer Disease.
Median enrollment 73 across the 1,608 interventional studies, 160 across the 309 observational. Of the 1,377 that completed or were terminated, 590 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
731 of 1,939 have an industry lead sponsor. The 10 most frequent:
Optina Diagnostics Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Optina Diagnostics Inc. has 3 studies filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
164 of the studies in Alzheimer Disease with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT05980949Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) | 2027-09-07 |
Add all 164 to your calendar (.ics) → With an account.
Among the 1,939 studies in Alzheimer Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The CAS test is an adjunct to other diagnostic evaluations, and is indicated for use with the Optina Diagnostics' MHRC (K200254).
This non-interventional, cross-sectional study is designed to validate a novel diagnostic test, the Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) test, for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (positive or negative). The CAS test is an adjunct to other diagnostic evaluations, and is indicated for use with the Optina Diagnostics' MHRC for imaging the retina. The study objective is to characterize the performance of the diagnostic CAS test in the target population of adult patients fifty (50) years and older with cognitive impairment, who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. The data generated in this study will provide evidence to be used in the assessment of the benefits and risks associated with use of the device in the intended population. The primary endpoint is to demonstrate accuracy of the Optina Diagnostics' CAS test compared to amyloid-PET status, as determined by a majority of three (3) qualified, independent PET Readers.
The target population for the Optina Diagnostics' CAS test is men and women 50 years and older who are under clinical investigation for cognitive impairment where Alzheimer's disease (AD) is one of the possible differential diagnoses.
As concomitant eye pathologies or conditions could interfere with CAS algorithm, individuals with certain ocular pathologies or conditions, including glaucoma, age-related macular degeneration (AMD), retinopathies, and advanced cataracts, will not be included in the target population at this time. Work is on-going to improve the CAS classifier algorithm with the goal to include these individuals in the target population at a later date.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Demonstrated cognitive impairment as evidenced by at least one of the following:
Exclusion Criteria:
Any ophthalmologic condition that would prevent obtaining retinal imaging and/or could interfere with the analysis of the MHRC images by the CAS, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Retinal beta-amyloid detection
Presence of absence of beta-amyloid plaques in the retina where the accuracy will be assessed using positive percent agreement (PPA) and negative percent agreement (NPA) with 95% confidence intervals.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Jul 2024, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Optina Diagnostics Inc.