Dementia With Lewy BodiesPhase 2COG1201NCT05225415
Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
A Phase 2 study testing CT1812 in people with Dementia With Lewy Bodies, run by Cognition Therapeutics at 34 sites in United States.
Trial summary
Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- CT1812
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 34 sitesUnited States
- Study dates
- 19 May 2022to 25 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- Other primary degenerative dementia (fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
- Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.).
- Seizure disorder.
Show all 9Show fewer
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
JEM Research Institute
Atlantis, Florida, 33462
University of Colorado
Aurora, Colorado, 80045
University of Miami Miller School of Medicine Comprehensive Center for Brain Health
Boca Raton, Florida, 33433
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
UNC Department of Neurology
Chapel Hill, North Carolina, 27599
University of Virginia Adult Neurology
Charlottesville, Virginia, 22903
Rush University Medical Center Section of Parkinson Disease and Movement Disorder
Chicago, Illinois, 60612
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern
Dallas, Texas, 75390
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, 80113
The University of Kansas Alzheimer's Disease Research Center
Fairway, Kansas, 66205
Clinical Trial Network
Houston, Texas, 77074
IU Health Neuroscience Center, Goodman Hall
Indianapolis, Indiana, 46202
Josephson Wallack Munshower Neurology, P.C
Indianapolis, Indiana, 46256
Evergreen Health Research
Kirkland, Washington, 98034
Charter Research
Lady Lake, Florida, 32156
University of Kentucky
Lexington, Kentucky, 40504
Columbia University
New York, New York, 10032
Renstar Medical Research
Ocala, Florida, 34770
Stanford University
Palo Alto, California, 94304
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
Headlands Research Eastern Massachusetts, LLC
Plymouth, Massachusetts, 02360
Summit Headlands, LLC
Portland, Oregon, 97210
Oregon Health and Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Pacific Neuroscience Institute
Santa Monica, California, 90404
Universtiy of Washington Department of Neurology
Seattle, Washington, 98104
New England Institute for Neurology and Headache (NEINH)
Stamford, Connecticut, 06905
Banner Sun Health Research Institute
Sun City, Arizona, 85351
University of Arizona - Health Sciences Center
Tucson, Arizona, 85724
Charter Research
Winter Park, Florida, 32792
About this study
Official title: 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
Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.
Read the detailed description
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.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- CT1812
- Keywords
- Dementia
- Medical subject headings
- Lewy Body Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT1812Drug
Orally administered CT1812
| Study group | Role | What they receive |
|---|---|---|
| CT1812 300 mg | Active comparator | CT1812 300 mg Receives: Drug: CT1812 |
| CT1812 100 mg | Active comparator | CT1812 100 mg Receives: Drug: CT1812 |
| Placebo | Placebo comparator | Placebo Receives: Drug: CT1812 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 210 Days
Secondary outcomes (8)
Montreal Cognitive Assessment Scale (MoCA)
MOCA is a dementia screening assessment with a 0-30 range with lower scores meaning more impairment
Measured: 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
Measured: 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
Measured: 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."
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, Day 28, Day 98, Day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start19 May 2022
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognition Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Anthony Caggiano, MD, Study director, Cognition Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225415
- Sponsor's protocol ID
- COG1201
- Other IDs
- R01AG071643
- Acronym
- COG1201
- Status last verified
- Feb 2026
- First submitted
- 11 Jan 2022
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Publications
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.
PubMed 41416579
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05225415
- Acronym / sponsor ID
- COG1201 / COG1201
- Conditions
- Dementia With Lewy Bodies
- Keywords
- Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Cognition TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 May 2022 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| CT1812 300 mg | Active comparator | Drug: CT1812CT1812 300 mg |
| CT1812 100 mg | Active comparator | Drug: CT1812CT1812 100 mg |
| Placebo | Placebo comparator | Drug: CT1812Placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT1812Orally administered CT1812 | Drug | CT1812 100 mg, CT1812 300 mg, Placebo |
Primary outcome
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 210 Days
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.
8 secondary outcomes
Montreal Cognitive Assessment Scale (MoCA)
Time frame: Baseline, Day 28, Day 98, and Day 182
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, Day 28, Day 98, and Day 182
Clinician Assessment of Fluctuation (CAF)
Time frame: Baseline, Day 28, Day 98, and Day 182
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Time frame: Day 28, Day 98, and Day 182
ADCS - Activities of Daily Living (ADCS-ADL)
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)
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
Time frame: Baseline and Day 182
Neuropsychiatric Inventory (NPI-12) - Domain: Total Score A-L (Frequency x Severity)
Time frame: Baseline, Day 28, Day 98, Day 182
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41416579Galvin 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.
- Title: "Together we can light the way for Dementia with Lewy Bodies research."Link provided by the sponsor.
Related trials for Dementia With Lewy Bodies
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Recruiting
Transcranial Alternating Current Stimulation in Lewy Body Dementia
Lewy Body Dementia (LBD), Transcranial Alternating Current Stimulation
RecruitingPhase 2
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Cognitive Dysfunction, Lewy Body Disease
RecruitingPhase 2
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
RecruitingPhase 3
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Caggiano, MD study director
Cognition Therapeutics Inc.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT1812 in people with Dementia With Lewy Bodies, run by Cognition Therapeutics at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 210 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.