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COG1201

CompletedPhase 2Results posted

Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies

A Randomized, Double-blind, Placebo-controlled, Phase 2, 6-month Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies

Asset

CT1812

Listed sites

34

Recruiting sites

-

Enrollment

130

actual

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•MMSE 18-27•MRI contraindications excluded

Primary endpoint

•Number of Study Participants With at Least One Mild, Moderate

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCOG1201
NCT IDNCT05225415
NihR01AG071643

Timeline

Milestones

Study first posted2022-02-04actual
Study start2022-05-19actual
Primary completion2024-11-25actual
Study completion2024-11-25actual
Last update posted2026-03-12actual
Results first posted2026-03-12actual

Assets

Drug assets

CT1812

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with Lewy Bodies (DLB).
•MRI, or CT scan due to contraindication of MRI if approved by medical monitor) obtained during screening consistent with the clinical diagnosis of DLB and without findings of significant exclusionary abnormalities. An historical MRI (or CT scan), up to 1 year prior to screening, may be used if there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.
•MMSE 18-27 inclusive

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:

1. Other primary degenerative dementia (fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).

2. Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.).

3. Seizure disorder.

4. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).

•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.

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
6
Global cognition
4
Function / daily living
2
Behavior / neuropsychiatric
2
Safety / tolerability / PK
2
Other clinical outcomes
2

Global cognition

4 endpoints
Secondary/protocol endpoint

Montreal Cognitive Assessment Scale (MoCA)

Time frame:Baseline, Day 28, Day 98, and Day 182

Montreal Cognitive Assessment (MoCA)

descriptive

Secondary/protocol endpoint

Change From Baseline in the Power of Attention Composite Score of the Cognitive Drug Research (CDR) System Battery

Time frame:Baseline and Day 182

change from baseline, improvement

Secondary/registry result

Montreal Cognitive Assessment Scale (MoCA)

Time frame:Baseline, Day 28, Day 98, and Day 182

Montreal Cognitive Assessment (MoCA)

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
CT1812 100 mgBaselinen=44 Participants19.54.34
Day 28n=43 Participants19.44.42
Day 98n=40 Participants19.45.06
Day182n=39 Participants19.35.37
CT1812 300 mgBaselinen=43 Participants17.85.42
Day 28n=43 Participants18.05.33
Day 98n=37 Participants17.26.06
Day182n=34 Participants17.45.89
PlaceboBaselinen=42 Participants17.94.62
Day 28n=40 Participants18.24.11
Day 98n=36 Participants18.44.14
Day182n=37 Participants17.65.24
Secondary/registry result

Change From Baseline in the Power of Attention Composite Score of the Cognitive Drug Research (CDR) System Battery

Time frame:Baseline and Day 182

change from baseline, improvement

Posted result

GroupValue (geometric_least_squares_mean), msecStandard error
CT1812 100 mgn=44 Participants119.89151.803
CT1812 300 mgn=44 Participants620.82157.701
Placebon=42 Participants279.62156.318

Function / daily living

2 endpoints
Secondary/protocol endpoint

ADCS - Activities of Daily Living (ADCS-ADL)

Time frame:Baseline, Day 28, Day 98, and Day 182

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Secondary/registry result

ADCS - Activities of Daily Living (ADCS-ADL)

Time frame:Baseline, Day 28, Day 98, and Day 182

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
CT1812 100 mgBaselinen=44 Participants62.710.33
Day 28n=43 Participants62.89.99
Day 98n=40 Participants61.810.83
Day 182n=40 Participants59.012.46
CT1812 300 mgBaselinen=44 Participants60.712.85
Day 28n=44 Participants61.212.64
Day 98n=37 Participants59.014.75
Day 182n=34 Participants58.216.20
PlaceboBaselinen=42 Participants63.39.77
Day 28n=40 Participants62.09.39
Day 98n=36 Participants60.511.85
Day 182n=37 Participants54.918.19

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI-12) - Domain: Total Score A-L (Frequency x Severity)

Time frame:Baseline, Day 28, Day 98, Day 182

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/registry result

Neuropsychiatric Inventory (NPI-12) - Domain: Total Score A-L (Frequency x Severity)

Time frame:Baseline, Day 28, Day 98, Day 182

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

GroupValue (mean), score on a scaleStandard deviation
CT1812 100 mgBaseline -NPI Total Score A-L (Frequency x Severity)n=44 Participants12.011.72
Day 28 -NPI Total Score A-L (Frequency x Severity)n=43 Participants9.89.82
Day 98 - NPI Total Score A-L (Frequency x Severity)n=40 Participants10.49.76
Day 182 -NPI Total Score A-L (Frequency x Severity)n=40 Participants12.513.84
CT1812 300 mgBaseline -NPI Total Score A-L (Frequency x Severity)n=43 Participants13.812.33
Day 28 -NPI Total Score A-L (Frequency x Severity)n=43 Participants10.511.67
Day 98 - NPI Total Score A-L (Frequency x Severity)n=37 Participants11.413.02
Day 182 -NPI Total Score A-L (Frequency x Severity)n=34 Participants13.013.19
PlaceboBaseline -NPI Total Score A-L (Frequency x Severity)n=42 Participants10.011.03
Day 28 -NPI Total Score A-L (Frequency x Severity)n=40 Participants7.99.19
Day 98 - NPI Total Score A-L (Frequency x Severity)n=36 Participants10.612.63
Day 182 -NPI Total Score A-L (Frequency x Severity)n=37 Participants15.818.03

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to 210 Days

event count, event

Primary/registry result

Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to 210 Days

event count, event

Posted result

GroupValue (number), participantsReported bounds
CT1812 100 mgAny Treatment Emergent Adverse Events (TEAE)n=44 Participants42-
Any TEAEs related to investigational product (IP)n=44 Participants14-
Any serious TEAEsn=44 Participants4-
Any serious TEAEs related to IPn=44 Participants0-
Any TEAEs with outcome of deathn=44 Participants0-
Any severe TEAEsn=44 Participants1-
Any severe TEAEs related to IPn=44 Participants0-
Any TEAEs leading to discontinuation of IPn=44 Participants4-
Any TEAEs related to IP leading to discontinuation of IPn=44 Participants2-
Any TEAEs leading to discontinuation of studyn=44 Participants4-
Any TEAEs related to IP leading to discontinuation of studyn=44 Participants2-
CT1812 300 mgAny Treatment Emergent Adverse Events (TEAE)n=43 Participants40-
Any TEAEs related to investigational product (IP)n=43 Participants21-
Any serious TEAEsn=43 Participants5-
Any serious TEAEs related to IPn=43 Participants1-
Any TEAEs with outcome of deathn=43 Participants2-
Any severe TEAEsn=43 Participants4-
Any severe TEAEs related to IPn=43 Participants1-
Any TEAEs leading to discontinuation of IPn=43 Participants9-
Any TEAEs related to IP leading to discontinuation of IPn=43 Participants7-
Any TEAEs leading to discontinuation of studyn=43 Participants9-
Any TEAEs related to IP leading to discontinuation of studyn=43 Participants7-
PlaceboAny Treatment Emergent Adverse Events (TEAE)n=42 Participants37-
Any TEAEs related to investigational product (IP)n=42 Participants16-
Any serious TEAEsn=42 Participants8-
Any serious TEAEs related to IPn=42 Participants0-
Any TEAEs with outcome of deathn=42 Participants1-
Any severe TEAEsn=42 Participants5-
Any severe TEAEs related to IPn=42 Participants0-
Any TEAEs leading to discontinuation of IPn=42 Participants5-
Any TEAEs related to IP leading to discontinuation of IPn=42 Participants2-
Any TEAEs leading to discontinuation of studyn=42 Participants2-
Any TEAEs related to IP leading to discontinuation of studyn=42 Participants0-

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

Time frame:Day 28, Day 98, and Day 182

threshold achievement, improvement

Secondary/registry result

Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

Time frame:Day 28, Day 98, and Day 182

threshold achievement, improvement

Posted result

GroupValue (number), participantsReported bounds
CT1812 100 mgMarked improvement - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants0-
Moderate improvement - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants0-
Minimal improvement -Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants8-
No change - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants24-
Minimal worsening - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants10-
Moderate worsening - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants1-
Marked worsening -Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants0-
Responders -Day 28n=43 Participants32-
Non-Responders -Day 28n=43 Participants11-
Marked improvement - Clinical Impression at Day 98 Subjects with a non-missing responsen=39 Participants0-
Moderate improvement - Clinical Impression at Day 98 Subjects with a non-missing responsen=39 Participants3-
Minimal improvement -Clinical Impression at Day 98 Subjects with a non-missing responsen=39 Participants6-
No change - Clinical Impression at Day 98 Subjects with a non-missing responsen=39 Participants8-
Minimal worsening - Clinical Impression at Day 98 Subjects with a non-missing responsen=39 Participants17-
Moderate worsening - Clinical Impression at Day 98 Subjects with a non-missing responsen=39 Participants5-
Marked worsening -Clinical Impression at Day 98 Subjects with a non-missing responsen=39 Participants0-
Responders - Day 98n=39 Participants17-
Non-Responders - Day 98n=39 Participants22-
Marked improvement - Clinical Impression at Day 182 Subjects with a non-missing responsen=39 Participants0-
Moderate improvement- Clinical Impression at Day 182 Subjects with a non-missing responsen=39 Participants2-
Minimal improvement- Clinical Impression at Day 182 Subjects with a non-missing responsen=39 Participants7-
No Change- Clinical Impression at Day 182 Subjects with a non-missing responsen=39 Participants7-
Minimal worsening -Clinical Impression at Day 182 Subjects with a non-missing responsen=39 Participants13-
Moderate worsening - Clinical Impression at Day 182 Subjects with a non-missing responsen=39 Participants9-
Marked worsening - Clinical Impression at Day 182 Subjects with a non-missing responsen=39 Participants1-
Responders - Day 182n=39 Participants16-
Non-Responders - Day 182n=44 Participants23-
CT1812 300 mgMarked improvement - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants0-
Moderate improvement - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants2-
Minimal improvement -Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants9-
No change - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants22-
Minimal worsening - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants10-
Moderate worsening - Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants0-
Marked worsening -Clinical Impression at Day 28 Subjects with a non-missing responsen=43 Participants0-
Responders -Day 28n=43 Participants33-
Non-Responders -Day 28n=43 Participants10-
Marked improvement - Clinical Impression at Day 98 Subjects with a non-missing responsen=37 Participants0-
Moderate improvement - Clinical Impression at Day 98 Subjects with a non-missing responsen=37 Participants0-
Minimal improvement -Clinical Impression at Day 98 Subjects with a non-missing responsen=37 Participants10-
No change - Clinical Impression at Day 98 Subjects with a non-missing responsen=37 Participants9-
Minimal worsening - Clinical Impression at Day 98 Subjects with a non-missing responsen=37 Participants15-
Moderate worsening - Clinical Impression at Day 98 Subjects with a non-missing responsen=37 Participants3-
Marked worsening -Clinical Impression at Day 98 Subjects with a non-missing responsen=37 Participants0-
Responders - Day 98n=37 Participants19-
Non-Responders - Day 98n=37 Participants18-
Marked improvement - Clinical Impression at Day 182 Subjects with a non-missing responsen=34 Participants0-
Moderate improvement- Clinical Impression at Day 182 Subjects with a non-missing responsen=34 Participants1-
Minimal improvement- Clinical Impression at Day 182 Subjects with a non-missing responsen=34 Participants2-
No Change- Clinical Impression at Day 182 Subjects with a non-missing responsen=34 Participants10-
Minimal worsening -Clinical Impression at Day 182 Subjects with a non-missing responsen=34 Participants15-
Moderate worsening - Clinical Impression at Day 182 Subjects with a non-missing responsen=34 Participants6-
Marked worsening - Clinical Impression at Day 182 Subjects with a non-missing responsen=34 Participants0-
Responders - Day 182n=34 Participants13-
Non-Responders - Day 182n=44 Participants21-
PlaceboMarked improvement - Clinical Impression at Day 28 Subjects with a non-missing responsen=40 Participants0-
Moderate improvement - Clinical Impression at Day 28 Subjects with a non-missing responsen=40 Participants0-
Minimal improvement -Clinical Impression at Day 28 Subjects with a non-missing responsen=40 Participants7-
No change - Clinical Impression at Day 28 Subjects with a non-missing responsen=40 Participants19-
Minimal worsening - Clinical Impression at Day 28 Subjects with a non-missing responsen=40 Participants13-
Moderate worsening - Clinical Impression at Day 28 Subjects with a non-missing responsen=40 Participants1-
Marked worsening -Clinical Impression at Day 28 Subjects with a non-missing responsen=40 Participants0-
Responders -Day 28n=40 Participants26-
Non-Responders -Day 28n=40 Participants14-
Marked improvement - Clinical Impression at Day 98 Subjects with a non-missing responsen=36 Participants1-
Moderate improvement - Clinical Impression at Day 98 Subjects with a non-missing responsen=36 Participants1-
Minimal improvement -Clinical Impression at Day 98 Subjects with a non-missing responsen=36 Participants3-
No change - Clinical Impression at Day 98 Subjects with a non-missing responsen=36 Participants11-
Minimal worsening - Clinical Impression at Day 98 Subjects with a non-missing responsen=36 Participants14-
Moderate worsening - Clinical Impression at Day 98 Subjects with a non-missing responsen=36 Participants6-
Marked worsening -Clinical Impression at Day 98 Subjects with a non-missing responsen=36 Participants0-
Responders - Day 98n=36 Participants16-
Non-Responders - Day 98n=36 Participants20-
Marked improvement - Clinical Impression at Day 182 Subjects with a non-missing responsen=37 Participants0-
Moderate improvement- Clinical Impression at Day 182 Subjects with a non-missing responsen=37 Participants1-
Minimal improvement- Clinical Impression at Day 182 Subjects with a non-missing responsen=37 Participants4-
No Change- Clinical Impression at Day 182 Subjects with a non-missing responsen=37 Participants5-
Minimal worsening -Clinical Impression at Day 182 Subjects with a non-missing responsen=37 Participants16-
Moderate worsening - Clinical Impression at Day 182 Subjects with a non-missing responsen=37 Participants10-
Marked worsening - Clinical Impression at Day 182 Subjects with a non-missing responsen=37 Participants1-
Responders - Day 182n=37 Participants10-
Non-Responders - Day 182n=37 Participants27-

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Epworth Sleepiness Scale (ESS)

Time frame:Baseline, Day 28, Day 98, and Day 182

descriptive

Secondary/protocol endpoint/low confidence

Clinician Assessment of Fluctuation (CAF)

Time frame:Baseline, Day 28, Day 98, and Day 182

descriptive

Secondary/protocol endpoint/low confidence

Movement Disorder Society - United Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III)

Time frame:Baseline, Day 28, Day 98, and Day 182

descriptive

Secondary/registry result/low confidence

Epworth Sleepiness Scale (ESS)

Time frame:Baseline, Day 28, Day 98, and Day 182

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
CT1812 100 mgBaselinen=44 Participants7.94.05
Day 28n=43 Participants7.34.60
Day 98n=40 Participants7.64.47
Day 182n=40 Participants8.84.58
CT1812 300 mgBaselinen=43 Participants9.24.40
Day 28n=43 Participants9.64.69
Day 98n=37 Participants10.15.38
Day 182n=34 Participants10.04.93
PlaceboBaselinen=42 Participants8.25.24
Day 28n=40 Participants8.84.97
Day 98n=36 Participants8.35.88
Day 182n=42 Participants8.65.40
Secondary/registry result/low confidence

Clinician Assessment of Fluctuation (CAF)

Time frame:Baseline, Day 28, Day 98, and Day 182

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
CT1812 100 mgBaselinen=44 Participants4.83.75
Day 28n=43 Participants4.33.88
Day 98n=37 Participants4.03.63
Day 182n=39 Participants4.93.68
CT1812 300 mgBaselinen=44 Participants5.93.43
Day 28n=44 Participants4.13.48
Day 98n=37 Participants4.43.89
Day 182n=33 Participants5.03.95
PlaceboBaselinen=42 Participants4.23.41
Day 28n=40 Participants4.93.89
Day 98n=36 Participants4.64.17
Day 182n=37 Participants5.74.77
Secondary/registry result/low confidence

Movement Disorder Society - United Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III)

Time frame:Baseline, Day 28, Day 98, and Day 182

descriptive

Posted result

GroupValue (mean), score on a scaleStandard deviation
CT1812 100 mgBaselinen=44 Participants29.213.93
Day 28n=43 Participants28.713.66
Day 98n=39 Participants29.314.98
Day 182n=39 Participants30.813.90
CT1812 300 mgBaselinen=43 Participants25.412.95
Day 28n=43 Participants23.312.63
Day 98n=37 Participants28.214.15
Day 182n=34 Participants28.915.31
PlaceboBaselinen=42 Participants28.113.41
Day 28n=40 Participants28.714.20
Day 98n=36 Participants30.815.91
Day 182n=37 Participants33.817.56

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.