Recent Updates
Recently added Catalysts

CT1812

Phase 2

Early Alzheimer's Disease | Small molecule | Neurology |Cognition Therapeutics, Inc.|Last Updated: Mar 12, 2026

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment540
FDA Designations
No designations recorded
Clinical trial landscape

CT1812 · 10 trials · 7 indications

Phase 2 4Phase 1 6
NCT05531656A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's DiseaseEarly Alzheimer's Disease
ACTIVE NOT_RECRUITING540 Analytics
NCT05225415Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy BodiesDementia With Lewy Bodies
COMPLETED130 Analytics
NCT04735536Pilot Clinical Study of CT1812 in Mild to Moderate Alzheimer's Disease Using EEGAlzheimer Disease
COMPLETED16 Analytics
NCT03507790A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.Mild to Moderate Alzheimer's Disease
COMPLETED153 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
Early Alzheimer's DiseaseUnlock trial analytics
PHASE2COMPLETED
Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
Dementia With Lewy BodiesUnlock trial analytics
PHASE2COMPLETED
Pilot Clinical Study of CT1812 in Mild to Moderate Alzheimer's Disease Using EEG
Alzheimer DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
Mild to Moderate Alzheimer's DiseaseUnlock trial analytics
Study Endpoints
Primary Endpoints
Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
18 months

The Clinical Dementia Rating (CDR) is a clinical scale that describes 5 levels of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia as absent, questionable, mild, moderate, or severe (global CDR scores of 0, 0.5, 1, 2, or 3, respectively). The score is based on interviews with the participant and study partner, using a structured interview. A sum of boxes score (CDR-SB) provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.

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

Number of TEAEs, Related TEAEs, SAEs, and Related SAEs
Up to 126 days

Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 22.0

Change in the Brain Activity Reflected by Changes of Spectral Power in Conventional Frequency Bands Measured by the Global Relative Theta (4-8 Hz) Power Obtained Through EEG Assessment.
Day 1 through Day 29 of Period 1 and Day 1 (study day 44) and Day 29 (study day 72) of Period 2

Global relative theta power was quantified and summarized descriptively (observed values, change from the pre-treatment values) by treatment and time point using the Safety Population. The change from period baseline in global relative theta power within each period was analyzed using a linear mixed model with fixed effects for treatment group (CT1812 or placebo), sequence, and period, and a random effect for subject within sequence. The analysis was conducted using PROC MIXED. The ability of CT1812 to rapidly restore synapse number to normal was expected to result in a decrease in EEG theta power in AD patients in response to short-term treatment with CT1812. Thus, a decrease in the Global Relative Theta Power represents better outcomes, while high values in the Global Relative Theta Power represent worse outcomes. The unit is represented by uV\^2/Hz (microvolt squared per frequency). This is a common unit for spectral power density, and how relative power measures are displayed.

Changes in Predose CT1812 Plasma Concentrations.
Baseline through Day 84: Pre and Post- Dose on Days 1, 29 AND Pre Dose Days 8, 15, 22.

For the measurements of pre-dose and post-dose plasma concentrations of CT1812, samples were collected 1± 0.25 hour predose. Single concentrations of CT1812 at selected predose and post-dose time points were reported.

Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs).
Up to 210 Days

Adverse events were captured from the start of study-related procedures at Visit 1 (including diagnostic assessments or signing of ICF) onward during the course of this study. Adverse events were coded using MedDRA Version 27.0.TEAEs are events that occurred or worsened on or after the first application of study drug. Participants are counted once for each system organ class (SOC) and once for each preferred term (PT).

Pharmacokinetics (PK) in plasma
Day 13 and 15.

Cmax: Maximum observed plasma concentration occurring at Tmax

Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Day 13 and 15.

Cmax - Maximum observed plasma concentration occurring at Tmax.

Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF)- CSF/plasma ratio
Day 13 and 15.

CSF/plasma ratio - Pre-dose on Day 13 and 3h (±15 min) post-dose on Day 15

Plasma CT1812 Concentration at 96 Hours Timepoint
Predose through 96 hours postdose

Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Plasma M6/CP199 Concentration at 144 Hours Timepoint
Predose through 144 hours postdose

Plasma concentrations of M6/CP199 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Plasma Total Radioactivity (TRA) Concentration CT1812-Equivalents at 168 Hours Timepoint
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Whole Blood Total Radioactivity (TRA) Concentration CT1812-Equivalents at 144 Hours Timepoint
Predose through 144 hours postdose

The analysis of Whole Blood Total Radioactivity Concentration of CT1812-Equivalents was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Urine
Predose and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours postdose, and every 24 hours (pooled) until Day 8 (168 hours postdose).

Cumulative radioactive dose (Cum%Dose) excreted in the urine was determined using Liquid Scintillation Counting (LSC) following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Feces
Predose, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hours postdose

Cumulative radioactive dose (Cum%Dose) excreted in the feces was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

CT1812 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

Plasma CT1812 Concentration were measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).

M6/CP199 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

M6/CP199 Plasma Concentration was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. M6/CP199 plasma concentrations were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).

Plasma Total Radioactivity According to AUC0-last Pharmacokinetic Parameter
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

Plasma Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC).

Whole Blood Total Radioactivity According to AUC0-last Pharmacokinetic Parameter
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

Whole Blood Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC)

Measuring the displacement of Amyloid beta oligomers into cerebrospinal fluid (CSF)
48 hours

evidence of oligomer displacement as demonstrated by a clear rise in CSF oligomer concentration relative to baseline and placebo

Area under the plasma-concentration time curve of CT1812 (Day 6) compared to the baseline values (Day -2)
10 days

Single dose (Day -2 and Day 6) pharmacokinetic parameter Area under the plasma-concentration time curve

Incidence and review of Treatment Emergent Adverse Events
Up to 30 days

Treatment Emergent Adverse Events will be assessed by reviewing: Physical Exams; monitoring of vital signs, ECGs, and clinical and laboratory assessments

Incidence and review of Treatment Emergent Adverse Events [Safety and Tolerability]
up to 35 days

Treatment Emergent Adverse Events will be assessed by reviewing: * physical examinations, * monitoring vital signs, * monitoring clinical and laboratory assessments, * monitoring ECGs.

Secondary Endpoints
Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)
18 months
Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.
18 months
Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.
18 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CT1812 100 mgACTIVE_COMPARATORCT1812 at a dose of 100 n=180 group
CT1812 200 mgACTIVE_COMPARATORCT1812 at a dose of 300mg, n=180 group
PlaceboPLACEBO_COMPARATORPlacebo, n=180 group
CT1812 300 mgACTIVE_COMPARATORCT1812 300 mg
Active Treatment- CT1812EXPERIMENTALActive Treatment- CT1812 at a dose of 300mg
Control - PlaceboPLACEBO_COMPARATORDrug: Placebo Non-active study drug
Active Treatment- CT1812 100 mgACTIVE_COMPARATORCT1812 at a dose of 100 mg
Active Treatment- CT1812 300 mgACTIVE_COMPARATORCT1812 at a dose of 300mg
Placebo Comparator - PlaceboPLACEBO_COMPARATORPlacebo
150 mg QDEXPERIMENTALCT1812 150 mg QD
150 mg BIDEXPERIMENTALCT1812 150 mg BID
300 mg QDEXPERIMENTALCT1812 300 mg QD
CT1812EXPERIMENTALInvestigational Drug
Active Treatment- CT1812 560 mgACTIVE_COMPARATOR -
Active Treatment- CT1812 280 mgACTIVE_COMPARATOR -
Active Treatment- CT1812 90 mgACTIVE_COMPARATOR -
Active Treatment-LowACTIVE_COMPARATOR6 subjects randomized to 280 mg (Low) CT1812
Active Treatment-HighACTIVE_COMPARATOR6 subjects randomized to 560 mg (High) CT1812
Matching PlaceboPLACEBO_COMPARATORIn cohorts 1-6, 8 subjects will be enrolled. 6 subjects will receive matching placebo.
Interventions
NameTypeDescription
CT1812DRUGStudy Drug
PlaceboDRUGNon-active study drug
300 mg [C14] CT1812DRUGSingle dose of 300 mg CT1812 with microtracer dose of \[C14\]
tolbutamideDRUGSingle-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of tolbutamide
dextromethorphanDRUGSingle-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of dextromethorphan
OmeprazoleDRUGSingle-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of omeprazole
midazolamDRUGSingle-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of midazolam
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: 1. Ages 50-85 years. 2. Diagnosis of either MCI due to AD or mild AD dementia. 3. MMSE 20-30 (inclusive). 4. Amyloid PET scan of the brain or CSF biomarkers consistent with AD. 5. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's ...

Countries:United StatesNetherlandsAustraliaCzechiaSpain
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05531656primaryCompletionDate: changed
LOWMay 24, 2026NCT05531656studyFirstPostDate: changed
MEDIUMMay 21, 2026NCT05225415TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT05225415TRIAL_REMOVED: changed