An interventional study of Spectris™ AD - Active and Spectris™ AD - Sham in Alzheimer Disease, Alzheimer Disease 1 and Alzheimer Disease 2, sponsored by Cognito Therapeutics, Inc.. Completed at 68 sites in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Cognito Therapeutics, Inc. · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 135th largest by enrollment of the 1,608 interventional ones that give a count, is one of 131 that started in 2022, is one of 608 with no phase, and was the 1,541st registered.
3,968 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 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 50 Years to 90 Years · all sexes · no healthy volunteers.
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 673 is above the median of 70 across 3,021 interventional 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:
Cognito Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Cognito Therapeutics, Inc. has 4 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 is a randomized, double-blind, sham-controlled pivotal study of sensory stimulation in subjects with mild to moderate AD. Up to approximately 670 subjects will be treated with either Active or Sham investigational device, Spectris™ AD, for 60 minutes daily for approximately 12 months. Efficacy will be measured using the Integrated Alzheimer's Disease Mini-Mental State Exam (MMSE) Activities of Daily Living (ADCS-ADL) Rating Scale (iADMARS).
This is a multicenter, randomized, double-blind, sham-controlled pivotal study.
The objective of this study is to assess the safety and efficacy of gamma sensory stimulation (visual and audio) via Spectris ™ AD in slowing cognitive-functional symptom worsening versus the Sham device for subjects with mild to moderate AD as measured by changes in function and cognition.
Up to approximately six hundred and seventy (670) subjects with Mild to Moderate AD (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Active : Sham). In the Active Group, subjects will be treated with the Active Spectris™ AD for 60 minutes daily. In the Sham Group, subjects are treated with a Sham Spectris™ AD for 60 minutes daily. Daily treatment is planned for approximately 12 months.
Subjects will attend study visits for informed consent, screening and baseline, then at 3-Months, 6-Months, 9-Months (by phone), 12 Months and 13 Months (for safety follow-up).
Some clinical sites will be included in a substudy evaluating additional fluid biomarkers. Select subjects enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.
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.
Exclusion Criteria:
Serious neurological diseases affecting the Central Nervous System, including:
Participants involved in the Fluid Biomarker substudy also must not have to lumbar puncture.
For more information visit: https://www.hopestudyforad.com/
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Active Group: Subjects are treated with the Active Spectris™ AD at home for 60 minutes daily for approximately 12 months.
Device: Spectris™ AD - Active
Sham Group: Subjects are treated with a Sham Spectris™ AD at home for 60 minutes daily for approximately 12 months
Device: Spectris™ AD - Sham
Spectris™ AD - Active settings
Spectris™ AD - Sham settings
Integrated Alzheimer's Disease MMSE ADCS-ADL Rating Scale (iADMARS)
Comparing the change from baseline (CFB) to 12 months in iADMARS between active vs sham groups.
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Alzheimer's Disease Cooperative Study-Activities of Daily Living ADCS-ADL
Function as measured by ADCS-ADL
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Mini-Mental State Examination (MMSE)
Cognition as measured by MMSE
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Alzheimer's Disease Cooperative Study- instrumental Activities of Daily Living (ADCS-iADL)
Function and cognition as measured by ADCS-iADL
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Jun 2026, 42 months.
Of 77 industry-sponsored interventional studies with no phase under Alzheimer Disease, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's 42 months is above that.
Counting every sponsor, half of 962 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cognito Therapeutics, Inc.