A Phase 2 interventional study of CT1812 in Dementia With Lewy Bodies, sponsored by Cognition Therapeutics. Completed at 34 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Cognition Therapeutics · Phase 2, Interventional, and Treatment
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Among 110 studies in Lewy Body Disease with a site in United States — 32 open to participants now, 40 under way, 1 of them phase 3. Lewy Body Disease · United States.
Among the 110 studies in Lewy Body Disease with a site in United States, this one is the 29th largest by enrollment of the 78 interventional ones that give a count, is one of 9 that started in 2022, is one of 21 in phase 2, and was the 70th registered.
239 studies on the registry are indexed under Lewy Body Disease; 88 are open to participants now.
Browse Lewy Body Disease studies →32 of the 110 studies in Lewy Body Disease with a site in United States are open now. Recruiting first, the newest first:
University of Washington · Sites in United States
Ages 18+
NYU Langone Health · Sites in United States
Ages 18–90 · Healthy volunteers
Eli Lilly and Company · Sites in United States, Japan, Korea, Republic of and 1 more country
Ages 55–85
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Sites in United States
Ages 18+
University of Pennsylvania · Sites in United States
Ages 18+ · 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 63 Lewy Body Disease studies recruiting now, 41 (65%) set no upper age limit and none (0%) stop at 75 or younger; 10 take children under 18; 31 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.
110 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 8 · Phase 2 24 · Phase 3 4 · Phase 4 8
First in 2002; this study’s year is marked. 9 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 130 is above the median of 89 across 152 interventional studies indexed under Lewy Body Disease.
Median enrollment 86 across the 78 interventional studies, 225 across the 31 observational. Of the 66 that completed or were terminated, 33 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 110 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 2 studies filed under Lewy Body Disease — fewer than ten, so there is no comparison to draw.
13 of the studies in Lewy Body Disease with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06098612Massachusetts General HospitalPET Imaging Evaluation of [11C]SY08 | 2026-11 |
| NCT01799915NYU Langone HealthNatural History Study of Synucleinopathies | 2026-12-30 |
| NCT03233646Duke UniversityRetinal Imaging in Neurodegenerative Disease | 2026-12-31 |
| NCT03702907Georgetown UniversityDC Longitudinal Study on Aging and Specimen Bank | 2027-01 |
| NCT04246437Daniel Claassen[18F]F-DOPA Imaging in Patients With Autonomic Failure | 2027-02-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 110 studies in Lewy Body 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.
Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.
The safety and efficacy of CT1812 at doses of 300 and 100mg will be evaluated over a 24 week double-blind treatment period in patient diagnosed with dementia with Lewy bodies.
Patients will be randomized 1:1:1 to placebo, 100mg CT1812 or 300mg CT1812. Oral CT1812 will be taken daily. Subjects meeting eligibility requirement and signing informed consent will be assessed by repeated psychometric/neurologic testing, safety procedures and PK and PD sample collection at defined intervals throughout the study. Plasma and CSF biomarkers will also be followed.
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:
Clinical, laboratory findings or medical history 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.
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.
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.
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.
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 300 mg
Drug: CT1812
CT1812 100 mg
Drug: CT1812
Placebo
Drug: CT1812
Orally administered CT1812
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
All adverse events (AE) summaries were restricted to TEAEs, which were defined as those AEs that occurred on or after the date of first dose and those existing AEs that worsened during the study. If it could not be determined whether the AE was treatment-emergent due to a partial onset date, then it was counted as such. Verbatim terms were mapped to System Organ Class (SOC) and preferred terms using MedDRA version 24.1.
Time frame: Up to 210 Days
Montreal Cognitive Assessment Scale (MoCA)
MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment
Time frame: Baseline, Day 28, Day 98, and Day 182
Epworth Sleepiness Scale (ESS)
The ESS is an assessment of subjective sleepiness over the prior two weeks. The scale is on 4 point scale (0 = no chance of dozing; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing) Total score sums up all sub-scores and can range from 0 to 24. A higher score is associated with increased sleepiness. An ESS score ≥10 is considered abnormal and consistent with excessive daytime sleepiness An ESS score \> 10 is considered consistent with excessive daytime sleepiness
Time frame: Baseline, Day 28, Day 98, and Day 182
Clinician Assessment of Fluctuation (CAF)
Assessment of cognitive fluctuations, with range of 1-16, with higher scores representing more severe fluctuations
Time frame: Baseline, Day 28, Day 98, and Day 182
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
The ADCS-CGIC is a 7-point scale similar to other global change scales, where a higher score indicates marked improvement. The 7 responses and corresponding numeric scores for each response of the ADCS-CGIC are: Marked improvement (1), Moderate improvement (2), Minimal improvement (3), No change (4), Minimal worsening (5), Moderate worsening (6), Marked worsening (7). The observed scores at each visit were summarized. A responder was defined as a participant who responded as "Marked improvement, Moderate improvement, Minimal improvement, No change" and non-responder was defined as a participant who responded as "Minimal worsening, Moderate worsening, Marked worsening."
Time frame: Day 28, Day 98, and Day 182
ADCS - Activities of Daily Living (ADCS-ADL)
Assessment of functional impairment in activities of daily living. The total score range is from 0-78 with lower scores indicating greater functional impairment.
Time frame: Baseline, Day 28, Day 98, and Day 182
Movement Disorder Society - United Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III)
This exam covers 18 motor signs associated with parkinsonism covering bradykinesia, rigidity, tremor, and gait with a range of scores from 0-136, with higher scores supporting more severe symptoms. A score of 6 or greater suggest the presence of parkinsonism
Time frame: Baseline, Day 28, Day 98, and Day 182
Change From Baseline in the Power of Attention Composite Score of the Cognitive Drug Research (CDR) System Battery
The CDR tests are designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition).Power of Attention is a composite score derived from the CDR that measures the intensity of concentration (i.e., the ability to focus attention). Faster responses indicate that greater cognitive processing resources are being applied to the task. Power of Attention is calculated as the sum of three cognitive function speed tests: simple reaction time, choice reaction time, and digit vigilance. Scores range from 450 milliseconds (msec) to 61,500 msec. Lower scores reflect faster reaction times and greater intensity of concentration. An increase from baseline, resulting in higher values, indicates worsening compared to the baseline assessment.
Time frame: Baseline and Day 182
Neuropsychiatric Inventory (NPI-12) - Domain: Total Score A-L (Frequency x Severity)
The Neuropsychiatric Inventory (NPI) was used to assess common neuropsychiatric symptoms associated with dementia. A structured caregiver interview was conducted to evaluate 12 behavioral domains, including delusions, hallucinations, dysphoria, euphoria, anxiety, agitation/aggression, apathy, irritability/lability, disinhibition, aberrant motor behavior, sleep disturbances, and appetite/eating disorders. Symptom frequency was rated on a 4-point scale (1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently), and symptom severity was rated on a 3-point scale (1 = mild, 2 = moderate, 3 = marked). Domain scores were calculated as the product of frequency and severity ratings. The total NPI score was calculated as the sum of all domain scores and ranges from 0 to 144 (12 domains, each with a maximum score of 12). Increases from baseline (higher scores) indicate worsening of symptoms.
Time frame: Baseline, Day 28, Day 98, Day 182
Thirty-one sites were selected in the United States: Arizona (2), California (2), Colorado (2), Connecticut (1), Florida (6), Illinois (1), Indiana (1), Kansas (1), Kentucky (1), Massachusetts (1), Minnesota (1), New York (1), North Carolina (1), Ohio (2), Oregon (2), Pennsylvania (1), Texas (1), Virginia (2), and Washington (2).
| Milestone | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Started | 44 | 44 | 42 |
| Completed | 40 | 33 | 36 |
| Not completed | 4 | 11 | 6 |
| Withdrew: Adverse event | 4 | 9 | 2 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 | 2 |
| Withdrew: Withdrawal by caregiver | 0 | 0 | 1 |
All adverse events (AE) summaries were restricted to TEAEs, which were defined as those AEs that occurred on or after the date of first dose and those existing AEs that worsened during the study. If it could not be determined whether the AE was treatment-emergent due to a partial onset date, then it was counted as such. Verbatim terms were mapped to System Organ Class (SOC) and preferred terms using MedDRA version 24.1.
| participants | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Any Treatment Emergent Adverse Events (TEAE) | 42 | 40 | 37 |
| Any TEAEs related to investigational product (IP) | 14 | 21 | 16 |
| Any serious TEAEs | 4 | 5 | 8 |
| Any serious TEAEs related to IP | 0 | 1 | 0 |
| Any TEAEs with outcome of death | 0 | 2 | 1 |
| Any severe TEAEs | 1 | 4 | 5 |
| Any severe TEAEs related to IP | 0 | 1 | 0 |
| Any TEAEs leading to discontinuation of IP | 4 | 9 | 5 |
| Any TEAEs related to IP leading to discontinuation of IP | 2 | 7 | 2 |
| Any TEAEs leading to discontinuation of study | 4 | 9 | 2 |
| Any TEAEs related to IP leading to discontinuation of study | 2 | 7 | 0 |
MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment
| score on a scale | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Baseline | 19.5 ± 4.34 | 17.8 ± 5.42 | 17.9 ± 4.62 |
| Day 28 | 19.4 ± 4.42 | 18.0 ± 5.33 | 18.2 ± 4.11 |
| Day 98 | 19.4 ± 5.06 | 17.2 ± 6.06 | 18.4 ± 4.14 |
| Day182 | 19.3 ± 5.37 | 17.4 ± 5.89 | 17.6 ± 5.24 |
The ESS is an assessment of subjective sleepiness over the prior two weeks. The scale is on 4 point scale (0 = no chance of dozing; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing) Total score sums up all sub-scores and can range from 0 to 24. A higher score is associated with increased sleepiness. An ESS score ≥10 is considered abnormal and consistent with excessive daytime sleepiness An ESS score \> 10 is considered consistent with excessive daytime sleepiness
| score on a scale | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Baseline | 7.9 ± 4.05 | 9.2 ± 4.40 | 8.2 ± 5.24 |
| Day 28 | 7.3 ± 4.60 | 9.6 ± 4.69 | 8.8 ± 4.97 |
| Day 98 | 7.6 ± 4.47 | 10.1 ± 5.38 | 8.3 ± 5.88 |
| Day 182 | 8.8 ± 4.58 | 10.0 ± 4.93 | 8.6 ± 5.40 |
Assessment of cognitive fluctuations, with range of 1-16, with higher scores representing more severe fluctuations
| score on a scale | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Baseline | 4.8 ± 3.75 | 5.9 ± 3.43 | 4.2 ± 3.41 |
| Day 28 | 4.3 ± 3.88 | 4.1 ± 3.48 | 4.9 ± 3.89 |
| Day 98 | 4.0 ± 3.63 | 4.4 ± 3.89 | 4.6 ± 4.17 |
| Day 182 | 4.9 ± 3.68 | 5.0 ± 3.95 | 5.7 ± 4.77 |
The ADCS-CGIC is a 7-point scale similar to other global change scales, where a higher score indicates marked improvement. The 7 responses and corresponding numeric scores for each response of the ADCS-CGIC are: Marked improvement (1), Moderate improvement (2), Minimal improvement (3), No change (4), Minimal worsening (5), Moderate worsening (6), Marked worsening (7). The observed scores at each visit were summarized. A responder was defined as a participant who responded as "Marked improvement, Moderate improvement, Minimal improvement, No change" and non-responder was defined as a participant who responded as "Minimal worsening, Moderate worsening, Marked worsening."
| participants | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Marked improvement - Clinical Impression at Day 28 Subjects with a non-missing response | 0 | 0 | 0 |
| Moderate improvement - Clinical Impression at Day 28 Subjects with a non-missing response | 0 | 2 | 0 |
| Minimal improvement -Clinical Impression at Day 28 Subjects with a non-missing response | 8 | 9 | 7 |
| No change - Clinical Impression at Day 28 Subjects with a non-missing response | 24 | 22 | 19 |
| Minimal worsening - Clinical Impression at Day 28 Subjects with a non-missing response | 10 | 10 | 13 |
| Moderate worsening - Clinical Impression at Day 28 Subjects with a non-missing response | 1 | 0 | 1 |
| Marked worsening -Clinical Impression at Day 28 Subjects with a non-missing response | 0 | 0 | 0 |
| Responders -Day 28 | 32 | 33 | 26 |
| Non-Responders -Day 28 | 11 | 10 | 14 |
| Marked improvement - Clinical Impression at Day 98 Subjects with a non-missing response | 0 | 0 | 1 |
| Moderate improvement - Clinical Impression at Day 98 Subjects with a non-missing response | 3 | 0 | 1 |
| Minimal improvement -Clinical Impression at Day 98 Subjects with a non-missing response | 6 | 10 | 3 |
| No change - Clinical Impression at Day 98 Subjects with a non-missing response | 8 | 9 | 11 |
| Minimal worsening - Clinical Impression at Day 98 Subjects with a non-missing response | 17 | 15 | 14 |
| Moderate worsening - Clinical Impression at Day 98 Subjects with a non-missing response | 5 | 3 | 6 |
| Marked worsening -Clinical Impression at Day 98 Subjects with a non-missing response | 0 | 0 | 0 |
| Responders - Day 98 | 17 | 19 | 16 |
| Non-Responders - Day 98 | 22 | 18 | 20 |
| Marked improvement - Clinical Impression at Day 182 Subjects with a non-missing response | 0 | 0 | 0 |
| Moderate improvement- Clinical Impression at Day 182 Subjects with a non-missing response | 2 | 1 | 1 |
| Minimal improvement- Clinical Impression at Day 182 Subjects with a non-missing response | 7 | 2 | 4 |
| No Change- Clinical Impression at Day 182 Subjects with a non-missing response | 7 | 10 | 5 |
| Minimal worsening -Clinical Impression at Day 182 Subjects with a non-missing response | 13 | 15 | 16 |
| Moderate worsening - Clinical Impression at Day 182 Subjects with a non-missing response | 9 | 6 | 10 |
| Marked worsening - Clinical Impression at Day 182 Subjects with a non-missing response | 1 | 0 | 1 |
| Responders - Day 182 | 16 | 13 | 10 |
| Non-Responders - Day 182 | 23 | 21 | 27 |
Assessment of functional impairment in activities of daily living. The total score range is from 0-78 with lower scores indicating greater functional impairment.
| score on a scale | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Baseline | 62.7 ± 10.33 | 60.7 ± 12.85 | 63.3 ± 9.77 |
| Day 28 | 62.8 ± 9.99 | 61.2 ± 12.64 | 62.0 ± 9.39 |
| Day 98 | 61.8 ± 10.83 | 59.0 ± 14.75 | 60.5 ± 11.85 |
| Day 182 | 59.0 ± 12.46 | 58.2 ± 16.20 | 54.9 ± 18.19 |
This exam covers 18 motor signs associated with parkinsonism covering bradykinesia, rigidity, tremor, and gait with a range of scores from 0-136, with higher scores supporting more severe symptoms. A score of 6 or greater suggest the presence of parkinsonism
| score on a scale | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Baseline | 29.2 ± 13.93 | 25.4 ± 12.95 | 28.1 ± 13.41 |
| Day 28 | 28.7 ± 13.66 | 23.3 ± 12.63 | 28.7 ± 14.20 |
| Day 98 | 29.3 ± 14.98 | 28.2 ± 14.15 | 30.8 ± 15.91 |
| Day 182 | 30.8 ± 13.90 | 28.9 ± 15.31 | 33.8 ± 17.56 |
The CDR tests are designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition).Power of Attention is a composite score derived from the CDR that measures the intensity of concentration (i.e., the ability to focus attention). Faster responses indicate that greater cognitive processing resources are being applied to the task. Power of Attention is calculated as the sum of three cognitive function speed tests: simple reaction time, choice reaction time, and digit vigilance. Scores range from 450 milliseconds (msec) to 61,500 msec. Lower scores reflect faster reaction times and greater intensity of concentration. An increase from baseline, resulting in higher values, indicates worsening compared to the baseline assessment.
| msec | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Change From Baseline in the Power of Attention Composite Score of the Cognitive Drug Research (CDR) System Battery | 119.89 ± 151.803 | 620.82 ± 157.701 | 279.62 ± 156.318 |
The Neuropsychiatric Inventory (NPI) was used to assess common neuropsychiatric symptoms associated with dementia. A structured caregiver interview was conducted to evaluate 12 behavioral domains, including delusions, hallucinations, dysphoria, euphoria, anxiety, agitation/aggression, apathy, irritability/lability, disinhibition, aberrant motor behavior, sleep disturbances, and appetite/eating disorders. Symptom frequency was rated on a 4-point scale (1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently), and symptom severity was rated on a 3-point scale (1 = mild, 2 = moderate, 3 = marked). Domain scores were calculated as the product of frequency and severity ratings. The total NPI score was calculated as the sum of all domain scores and ranges from 0 to 144 (12 domains, each with a maximum score of 12). Increases from baseline (higher scores) indicate worsening of symptoms.
| score on a scale | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| Baseline -NPI Total Score A-L (Frequency x Severity) | 12.0 ± 11.72 | 13.8 ± 12.33 | 10.0 ± 11.03 |
| Day 28 -NPI Total Score A-L (Frequency x Severity) | 9.8 ± 9.82 | 10.5 ± 11.67 | 7.9 ± 9.19 |
| Day 98 - NPI Total Score A-L (Frequency x Severity) | 10.4 ± 9.76 | 11.4 ± 13.02 | 10.6 ± 12.63 |
| Day 182 -NPI Total Score A-L (Frequency x Severity) | 12.5 ± 13.84 | 13.0 ± 13.19 | 15.8 ± 18.03 |
Collected over Up to 210 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CT1812 100 mg | 0/44 (0%) | 4/44 (9.1%) | 42/44 (95.5%) |
| CT1812 300 mg | 2/43 (4.7%) | 5/43 (11.6%) | 40/43 (93%) |
| Placebo | 1/42 (2.4%) | 8/42 (19%) | 37/42 (88.1%) |
| Event | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 0/44 | 0/43 | 1/42 |
| CellulitisInfections and infestations | 0/44 | 0/43 | 1/42 |
| Klebsiella sepsisInfections and infestations | 0/44 | 0/43 | 1/42 |
| FallInjury, poisoning and procedural complications | 0/44 | 0/43 | 1/42 |
| Periprosthetic fractureInjury, poisoning and procedural complications | 0/44 | 0/43 | 1/42 |
| Scapula fractureInjury, poisoning and procedural complications | 0/44 | 0/43 | 1/42 |
| Cauda equina syndromeNervous system disorders | 0/44 | 0/43 | 1/42 |
| EncephalopathyNervous system disorders | 0/44 | 0/43 | 1/42 |
| HeadacheNervous system disorders | 0/44 | 0/43 | 1/42 |
| SyncopeNervous system disorders | 0/44 | 0/43 | 1/42 |
| Event | CT1812 100 mg | CT1812 300 mg | Placebo |
|---|---|---|---|
| FallInjury, poisoning and procedural complications | 7/44 | 14/43 | 10/42 |
| HeadacheNervous system disorders | 4/44 | 7/43 | 8/42 |
| Urinary tract infectionInfections and infestations | 3/44 | 3/43 | 8/42 |
| Lipase increasedEndocrine disorders | 5/44 | 7/43 | 6/42 |
| Alanine aminotransferase increasedMetabolism and nutrition disorders | 3/44 | 7/43 | 0/42 |
| DizzinessNervous system disorders | 3/44 | 4/43 | 5/42 |
| DiarrheaGastrointestinal disorders | 4/44 | 5/43 | 2/42 |
| COVID-19Infections and infestations | 3/44 | 5/43 | 3/42 |
| Aspartate aminotransferase increasedMetabolism and nutrition disorders | 4/44 | 5/43 | 0/42 |
| Confusional statePsychiatric disorders | 1/44 | 5/43 | 3/42 |
The intent-to-treat (ITT) population included all participants that were randomly assigned to study drug.
| Age, Continuous(years) | CT1812 100 mg | CT1812 300 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 72.6 ± 7.82 | 72.1 ± 5.90 | 73.7 ± 6.25 | 72.8 ± 6.69 |
| Sex: Female, Male(Participants) | CT1812 100 mg | CT1812 300 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 35 | 38 | 33 | 106 |
| Male | 9 | 6 | 9 | 24 |
| Ethnicity (NIH/OMB)(Participants) | CT1812 100 mg | CT1812 300 mg | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 43 | 44 | 39 | 126 |
| Unknown or Not Reported | 1 | 0 | 3 | 4 |
| Race (NIH/OMB)(Participants) | CT1812 100 mg | CT1812 300 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 3 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 | 2 |
| White | 42 | 39 | 38 | 119 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 | 6 |
| BMI(kg/m^2) | CT1812 100 mg | CT1812 300 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 26.5 ± 4.49 | 26.8 ± 3.41 | 26.4 ± 4.44 | 26.6 ± 4.12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2022 to primary completion in Nov 2024, 30 months.
Results were first posted in Mar 2026, 1 year 3 months after primary completion.
Of 24 phase 2 interventional studies under Lewy Body Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 30 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. 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