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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG071643 | U.S. NIH Grant/Contract | View source |
Not provided
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT1812 300 mg | Active Comparator | CT1812 300 mg |
|
| CT1812 100 mg | Active Comparator | CT1812 100 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT1812 | Drug | Orally administered CT1812 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 210 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment Scale (MoCA) | MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment | Baseline, Day 28, Day 98, and Day 182 |
| Epworth Sleepiness Scale (ESS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the subject's DLB, including any co-morbidities detected by clinical assessment or MRI (or CT scan due to contraindication of MRI, if approved by medical monitor)
Screening MRI (or historical MRI or CT scan due to contraindication of MRI if approved by medical monitor) or historical MRI/CT scan, if applicable. of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility.
Clinical, laboratory findings or medical history consistent with:
Any major psychiatric diagnosis, including schizophrenia, bipolar disorder, and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Caggiano, MD | Cognition Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Banner Sun Health Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41416579 | Derived | Galvin JE, Tolea MI, Scharre DW, Hamby ME, Iaci JF, Grundman M, Caggiano AO. Phase 2 study of zervimesine (CT1812) in participants with mild-to-moderate dementia with Lewy bodies (DLB). Alzheimers Dement. 2025 Dec;21(12):e71004. doi: 10.1002/alz.71004. |
Not provided
Not provided
130 participants met inclusion criteria and were randomized to treatment. The safety population included all participants in the intent-to-treat (ITT) population who received at least one dose of study drug. All 130 randomized participants were included in the ITT population. Participant 113-002, (CT1812 300 mg group), permanently discontinued from the study before study treatment administration due to withdrawal by participant and was not included in the safety population.
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CT1812 100 mg | CT1812 100 mg CT1812: Orally administered CT1812 |
| FG001 | CT1812 300 mg | CT1812 300 mg CT1812: Orally administered CT1812 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2022 | Nov 10, 2025 |
Not provided
Not provided
Double-blind, placebo-controlled
Not provided
Not provided
Not provided
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
| 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 | 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." | 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. | 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 | 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. | 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. | Baseline, Day 28, Day 98, Day 182 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| University of Arizona - Health Sciences Center | Tucson | Arizona | 85724 | United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Pacific Neuroscience Institute | Santa Monica | California | 90404 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| CenExel Rocky Mountain Clinical Research, LLC | Englewood | Colorado | 80113 | United States |
| New England Institute for Neurology and Headache (NEINH) | Stamford | Connecticut | 06905 | United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| University of Miami Miller School of Medicine Comprehensive Center for Brain Health | Boca Raton | Florida | 33433 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| Charter Research | Lady Lake | Florida | 32156 | United States |
| Renstar Medical Research | Ocala | Florida | 34770 | United States |
| Charter Research | Winter Park | Florida | 32792 | United States |
| Rush University Medical Center Section of Parkinson Disease and Movement Disorder | Chicago | Illinois | 60612 | United States |
| IU Health Neuroscience Center, Goodman Hall | Indianapolis | Indiana | 46202 | United States |
| Josephson Wallack Munshower Neurology, P.C | Indianapolis | Indiana | 46256 | United States |
| The University of Kansas Alzheimer's Disease Research Center | Fairway | Kansas | 66205 | United States |
| University of Kentucky | Lexington | Kentucky | 40504 | United States |
| Headlands Research Eastern Massachusetts, LLC | Plymouth | Massachusetts | 02360 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Columbia University | New York | New York | 10032 | United States |
| UNC Department of Neurology | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Summit Headlands, LLC | Portland | Oregon | 97210 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Clinical Trial Network | Houston | Texas | 77074 | United States |
| University of Virginia Adult Neurology | Charlottesville | Virginia | 22903 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Evergreen Health Research | Kirkland | Washington | 98034 | United States |
| Universtiy of Washington Department of Neurology | Seattle | Washington | 98104 | United States |
| FG002 | Placebo | Placebo CT1812: Orally administered CT1812 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent-to-treat (ITT) population included all participants that were randomly assigned to study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CT1812 100 mg | CT1812 100 mg CT1812: Orally administered CT1812 |
| BG001 | CT1812 300 mg | CT1812 300 mg CT1812: Orally administered CT1812 |
| BG002 | Placebo | Placebo CT1812: Orally administered CT1812 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The safety population included all participants in the intent-to-treat (ITT) population who received at least one dose of study drug. All 130 (100%) randomized participants were included in the ITT population. Participant 113-0002, randomized to the CT1812 300 mg group, permanently discontinued from the study before study treatment administration due to withdrawal by participant, and was not included in the safety population. | Posted | Number | participants | Up to 210 Days |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Montreal Cognitive Assessment Scale (MoCA) | MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment | The ITT population was used in this analysis. This population included all participants that were randomly assigned to study drug. Participants in this population were analyzed according to the treatment to which they had been randomized, regardless of what treatment they received. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 28, Day 98, and Day 182 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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 | The ITT population was used in this analysis. This population included all participants that were randomly assigned to study drug. Participants in this population were analyzed according to the treatment to which they had been randomized, regardless of what treatment they received. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 28, Day 98, and Day 182 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinician Assessment of Fluctuation (CAF) | Assessment of cognitive fluctuations, with range of 1-16, with higher scores representing more severe fluctuations | The ITT population was used in this analysis. This population included all participants that were randomly assigned to study drug. Participants in this population were analyzed according to the treatment to which they had been randomized, regardless of what treatment they received. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 28, Day 98, and Day 182 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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." | The ITT population was used in this analysis. This population included all participants that were randomly assigned to study drug. Participants in this population were analyzed according to the treatment to which they had been randomized, regardless of what treatment they received. | Posted | Number | participants | Day 28, Day 98, and Day 182 |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population was used in this analysis. This population included all participants that were randomly assigned to study drug. Participants in this population were analyzed according to the treatment to which they had been randomized, regardless of what treatment they received. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 28, Day 98, and Day 182 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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 | The ITT population was used in this analysis. This population included all participants that were randomly assigned to study drug. Participants in this population were analyzed according to the treatment to which they had been randomized, regardless of what treatment they received. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 28, Day 98, and Day 182 |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population was used in this analysis. This population included all participants that were randomly assigned to study drug. Participants in this population were analyzed according to the treatment to which they had been randomized, regardless of what treatment they received. | Posted | Geometric Least Squares Mean | Standard Error | msec | Baseline and Day 182 |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population was used in this analysis. This population included all participants that were randomly assigned to study drug. Participants in this population were analyzed according to the treatment to which they had been randomized, regardless of what treatment they received. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 28, Day 98, Day 182 |
|
Up to 210 Days
Participant 113-0002, randomized to the CT1812 300 mg group, permanently discontinued from the study before study treatment administration due to withdrawal by participant/legally authorized representative, and was not included in the safety population. All AEs were collected and reported on the Adverse Event Report Form during the course of the study (i.e., from the signing of the ICF through the Follow-up Visit).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT1812 100 mg | CT1812 100 mg CT1812: Orally administered CT1812 | 0 | 44 | 4 | 44 | 42 | 44 |
| EG001 | CT1812 300 mg | CT1812 300 mg CT1812: Orally administered CT1812 | 2 | 43 | 5 | 43 | 40 | 43 |
| EG002 | Placebo | Placebo CT1812: Orally administered CT1812 | 1 | 42 | 8 | 42 | 37 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA version 24.1 | Systematic Assessment |
| |
| Subcutaneous hematoma | Injury, poisoning and procedural complications | MedDRA version 24.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA version 24.1 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 24.1 | Systematic Assessment | In the CT1812 300 mg group, 1 participant died because of a serious TEAE of pneumonia aspiration |
|
| Death | General disorders | MedDRA 24.1 | Systematic Assessment | In the CT1812 300 mg group, 1 participant died because of unspecified reason (reported PT: death). |
|
| Klebsiella sepsis. | Infections and infestations | MedDRA 24.1 | Systematic Assessment | In the placebo group, 1 participant died because of a serious TEAE of Klebsiella sepsis. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lipase increased | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anxiety | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Caggiano | Cogntion Therapeutics Inc | 914-221-6730 | acaggiano@cogrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2024 | Nov 10, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Any serious TEAEs |
|
| Any serious TEAEs related to IP |
|
| Any TEAEs with outcome of death |
|
| Any severe TEAEs |
|
| Any severe TEAEs related to IP |
|
| Any TEAEs leading to discontinuation of IP |
|
| Any TEAEs related to IP leading to discontinuation of IP |
|
| Any TEAEs leading to discontinuation of study |
|
| Any TEAEs related to IP leading to discontinuation of study |
|
|
|
|
|
Placebo CT1812: Orally administered CT1812 |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
CT1812 300 mg CT1812: Orally administered CT1812 |
| OG002 | Placebo | Placebo CT1812: Orally administered CT1812 |
|
|
CT1812 300 mg
CT1812: Orally administered CT1812
| OG002 | Placebo | Placebo CT1812: Orally administered CT1812 |
|
|