A Phase 2 interventional study of CT1812 and Placebo in Mild to Moderate Alzheimer's Disease, sponsored by Cognition Therapeutics. Completed at 32 sites in 5 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Cognition Therapeutics · Phase 2, Interventional, and Treatment
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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 522nd largest by enrollment of the 1,608 interventional ones that give a count, is one of 104 that started in 2018, is one of 360 in phase 2, and was the 957th 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 85 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. 104 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 153 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:
Cognition Therapeutics is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Cognition Therapeutics has 9 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 multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).
This Phase 2 study is designed to evaluate the safety of two doses of CT1812 administered once daily for 6 months in adults aged 50 to 85 who have been diagnosed with mild to moderate Alzheimer's disease. Randomized participants will receive 100 mg of CT1812, 300 mg of CT1812, or placebo once daily for 182 days. Exploratory endpoints that evaluate the effect of CT1812 on biomarkers are also included.
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.
Men, and women of non-, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
i) Non-childbearing potential for women is defined as (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed.
ii) Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using an acceptable means of . Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap.
Exclusion Criteria:
Clinical or laboratory findings consistent with:
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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 American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CT1812 at a dose of 100 mg
Drug: CT1812
CT1812 at a dose of 300mg
Drug: CT1812
Placebo
Drug: Placebo
Active Study Drug
Also known as: Study Drug, zervimesine
Non-active study drug
Also known as: Matching Placebo
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
Time frame: Up to 210 Days
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs).
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
Time frame: Up to 210 Days
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers
Change from baseline in CSF-Aβ, Tau, phospho-Tau, neurogranin, synaptotagmin, synaptosomal-associated protein-25 (SNAP25), neurofilament light chain (NfL), and Aβ-oligomers.Change from baseline is calculated as the observed value minus the baseline value.
Time frame: Baseline to Day 182
Amyloid Beta 1-42/Amyloid Beta 1-40 (Aβ42/40) in the Cerebrospinal Fluid (CSF) Biomarkers
Ratio of Amyloid Beta 1-42 (Aβ42) to Amyloid Beta 1-40 (Aβ40) Concentration from Baseline to Day 182.
Time frame: Baseline to Day 182
The study was conducted in 12 centers in the United States, 3 centers in Australia, 3 centers in the Netherlands, 8 centers in Czech Republic, and 4 centers in Spain.
| Milestone | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo |
|---|---|---|---|
| Started | 51 | 51 | 51 |
| Completed | 47 | 35 | 46 |
| Not completed | 4 | 16 | 5 |
| Withdrew: Adverse event | 0 | 11 | 3 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Subject moved to another location | 1 | 2 | 0 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 1 |
| Withdrew: Covid 19 pandemic | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Discontinuation of the trial at the site | 1 | 1 | 0 |
| Withdrew: Randomized in error | 0 | 0 | 1 |
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
| Participants | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo |
|---|---|---|---|
| All TEAEs | 36 | 42 | 39 |
| Mild TEAEs | 19 | 22 | 22 |
| Moderate TEAEs | 16 | 16 | 14 |
| Severe TEAEs | 1 | 4 | 3 |
Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).
| Participants | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo |
|---|---|---|---|
| Participants with at least one TEAE | 36 | 42 | 39 |
| Participants with at least one TEAE related to treatment | 11 | 16 | 7 |
| Participants with a TEAE leading to study drug discontinuation | 0 | 11 | 3 |
| Participants with a TEAE leading to death | 0 | 0 | 1 |
| Participants with at least one SAE | 2 | 3 | 5 |
| Participants with at least one SAE related to treatment | 0 | 1 | 0 |
Change from baseline in CSF-Aβ, Tau, phospho-Tau, neurogranin, synaptotagmin, synaptosomal-associated protein-25 (SNAP25), neurofilament light chain (NfL), and Aβ-oligomers.Change from baseline is calculated as the observed value minus the baseline value.
| ng/L | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo |
|---|---|---|---|
| Alpha Synuclein Protein (ASYNP) (ng/L) - Concentration change in CSF from Baseline to Day 182 | 48.6 ± 625.13 | 38.3 ± 213.10 | -831.2 ± 3056.97 |
| Amyloid Beta 1-40 (Aβ40) (ng/L) -Concentration change in CSF from Baseline to Day 182 | -573.9 ± 2228.80 | -1076.7 ± 1781.36 | -17.9 ± 1633.79 |
| Amyloid Beta 1-42 (Aβ42) (ng/L) -Concentration change in CSF from Baseline to Day 182 | -13.5 ± 105.66 | -72.1 ± 121.62 | 3.1 ± 90.90 |
| Glial Fibrillary Acidic Protein (GFAP) (ng/L) - Concentration change in CSF from Baseline to Day 182 | -81.9 ± 457.85 | -87.4 ± 176.01 | -69.1 ± 321.21 |
| Neurofilament Light Chain Protein (NFLP) (ng/L) Concentration change in CSF from Baseline to Day 182 | 72.8 ± 317.59 | -55.5 ± 262.24 | 297.7 ± 535.60 |
| Neurogranin (NRGR) (ng/L) - Concentration change in CSF from Baseline to Day 182 | 19.70 ± 82.557 | -22.77 ± 68.348 | -16.93 ± 44.348 |
| Phosphorylated Tau Protein 181 (pTau181) (ng/L) Concentration change in CSF from Baseline to Day 182 | -0.74 ± 37.227 | -9.76 ± 45.506 | -4.03 ± 13.185 |
| Synaptosomal-Associated Protein 25 (SNAP25) Concentration change in CSF from Baseline to Day 182 | -0.88 ± 6.485 | -1.64 ± 4.767 | -1.04 ± 3.763 |
| Synaptotagmin (SYN) Concentration change in CSF from Baseline to Day 182 | 0.75 ± 15.041 | -19.44 ± 98.693 | 4.66 ± 56.365 |
| Tau Protein (TPROT) (ng/L) Concentration change in CSF from Baseline to Day 182 | -8.4 ± 204.92 | -47.8 ± 358.68 | -9.4 ± 80.67 |
Ratio of Amyloid Beta 1-42 (Aβ42) to Amyloid Beta 1-40 (Aβ40) Concentration from Baseline to Day 182.
| ratio | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo |
|---|---|---|---|
| Amyloid Beta 1-42/Amyloid Beta 1-40 (Aβ42/40) in the Cerebrospinal Fluid (CSF) Biomarkers | 0.019 ± 0.0766 | -0.024 ± 0.0631 | -0.002 ± 0.0594 |
Collected over Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Treatment- CT1812 100 mg | 0/51 (0%) | 2/51 (3.9%) | 25/51 (49%) |
| Active Treatment- CT1812 300 mg | 0/51 (0%) | 3/51 (5.9%) | 25/51 (49%) |
| Placebo Comparator - Placebo | 1/50 (2%) | 5/50 (10%) | 33/50 (66%) |
| Event | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo |
|---|---|---|---|
| Syncope x2Nervous system disorders | 0/51 | 0/51 | 1/50 |
| Bradycardia (intermittent)Cardiac disorders | 0/51 | 0/51 | 1/50 |
| Renal Oncocytosis (left kidney)Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/51 | 0/51 | 1/50 |
| Papillary Renal Cell Carcinoma (left kidney)Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/51 | 0/51 | 1/50 |
| Retinal Detachment Right SideEye disorders | 0/51 | 0/51 | 1/50 |
| DeliriumPsychiatric disorders | 0/51 | 0/51 | 1/50 |
| Acute Renal FailureRenal and urinary disorders | 0/51 | 0/51 | 1/50 |
| Lung Neoplasia Inferior Right with Metastasis in Liver and BonesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/51 | 0/51 | 1/50 |
| StomatitisGastrointestinal disorders | 1/51 | 0/51 | 0/50 |
| ConstipationGastrointestinal disorders | 1/51 | 0/51 | 0/50 |
| Event | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 3/51 | 8/51 | 5/50 |
| HeadacheNervous system disorders | 4/51 | 0/51 | 7/50 |
| FallInjury, poisoning and procedural complications | 7/51 | 2/51 | 4/50 |
| NasopharyngitisInfections and infestations | 0/51 | 3/51 | 4/50 |
| Post lumbar puncture syndromeInjury, poisoning and procedural complications | 2/51 | 0/51 | 4/50 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/51 | 1/51 | 4/50 |
| Upper respiratory tract infectionInfections and infestations | 2/51 | 2/51 | 3/50 |
| Alanine aminotransferase increasedInvestigations | 0/51 | 3/51 | 0/50 |
| Skin lacerationInjury, poisoning and procedural complications | 3/51 | 0/51 | 0/50 |
| Hepatic enzyme increasedInvestigations | 0/51 | 3/51 | 0/50 |
One participant in the placebo arm was randomized in error and did not receive the study drug after informing the site, post-randomization and prior to dosing, about a prohibited concomitant medication. Therefore, the number of participants in the placebo arm is 50, not 51.
| Age, Continuous(years) | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo | Total |
|---|---|---|---|---|
| Mean | 72.4 ± 6.96 | 74.1 ± 7.14 | 71.6 ± 7.97 | 72.7 ± 7.39 |
| Sex: Female, Male(Participants) | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo | Total |
|---|---|---|---|---|
| Female | 34 | 29 | 28 | 91 |
| Male | 17 | 22 | 22 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 1 | 11 |
| Not Hispanic or Latino | 47 | 44 | 49 | 140 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 0 | 1 | 2 | 3 |
| White | 50 | 49 | 47 | 146 |
| More than one race | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Height(cm) | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo | Total |
|---|---|---|---|---|
| Mean | 165.77 ± 9.143 | 165.88 ± 11.802 | 167.52 ± 9.998 | 166.39 ± 10.335 |
| Weight(Kg) | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo | Total |
|---|---|---|---|---|
| Mean | 72.01 ± 15.105 | 67.85 ± 13.268 | 68.10 ± 12.672 | 69.33 ± 13.770 |
| BMI(kg/m^2) | Active Treatment- CT1812 100 mg | Active Treatment- CT1812 300 mg | Placebo Comparator - Placebo | Total |
|---|---|---|---|---|
| Mean | 26.04 ± 4.574 | 24.43 ± 3.554 | 24.13 ± 3.046 | 24.87 ± 3.846 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2018 to primary completion in May 2024, 67 months.
Results were first posted in Aug 2025, 1 year 2 months after primary completion.
Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's 67 months is above that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zervimesine
Cognition Therapeutics