Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease. (NCT NCT03507790)

Last Updated: 2025-08-11

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

153 participants

Primary outcome timeframe

Up to 210 Days

Results posted on

2025-08-11

Participant Flow

The study was conducted in 12 centers in the United States, 3 centers in Australia, 3 centers in the Netherlands, 8 centers in Czech Republic, and 4 centers in Spain.

A total of 372 participants were screened, and 153 were randomized: 51 to CT1812 100 mg, 51 to CT1812 300 mg, and 51 to placebo. Study drug was administered to all participants in the CT1812 groups (100%) and to 50 participants (98.0%) in the placebo group. One participant in the placebo arm was randomized in error and did not receive study drug after informing the site post-randomization and prior to dosing of a prohibited concomitant medication.

Participant milestones

Participant milestones
Measure	Active Treatment- CT1812 100 mg CT1812 at a dose of 100 mg CT1812: Active Study Drug	Active Treatment- CT1812 300 mg CT1812 at a dose of 300 mg CT1812: Active Study Drug	Placebo Comparator - Placebo Placebo Placebo: Non-active study drug
Overall Study STARTED	51	51	51
Overall Study COMPLETED	47	35	46
Overall Study NOT COMPLETED	4	16	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Treatment- CT1812 100 mg CT1812 at a dose of 100 mg CT1812: Active Study Drug	Active Treatment- CT1812 300 mg CT1812 at a dose of 300 mg CT1812: Active Study Drug	Placebo Comparator - Placebo Placebo Placebo: Non-active study drug
Overall Study Adverse Event	0	11	3
Overall Study Withdrawal by Subject	2	0	0
Overall Study Subject moved to another location	1	2	0
Overall Study Non-compliance with study drug	0	0	1
Overall Study COVID 19 Pandemic	0	1	0
Overall Study Lost to Follow-up	0	1	0
Overall Study Discontinuation of the trial at the site	1	1	0
Overall Study Randomized in error	0	0	1

Baseline Characteristics

Two subjects-one in the CT1812 100 mg arm and one in the CT1812 300 mg arm-missed the baseline height measurement.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment- CT1812 100 mg n=51 Participants CT1812 at a dose of 100 mg CT1812: Active Study Drug	Active Treatment- CT1812 300 mg n=51 Participants CT1812 at a dose of 300 mg CT1812: Active Study Drug	Placebo Comparator - Placebo n=50 Participants Placebo Placebo: Non-active study drug	Total n=152 Participants Total of all reporting groups
Age, Continuous	72.4 years STANDARD_DEVIATION 6.96 • n=51 Participants	74.1 years STANDARD_DEVIATION 7.14 • n=51 Participants	71.6 years STANDARD_DEVIATION 7.97 • n=50 Participants	72.7 years STANDARD_DEVIATION 7.39 • n=152 Participants
Sex: Female, Male Female	34 Participants n=51 Participants	29 Participants n=51 Participants	28 Participants n=50 Participants	91 Participants n=152 Participants
Sex: Female, Male Male	17 Participants n=51 Participants	22 Participants n=51 Participants	22 Participants n=50 Participants	61 Participants n=152 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=51 Participants	6 Participants n=51 Participants	1 Participants n=50 Participants	11 Participants n=152 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=51 Participants	44 Participants n=51 Participants	49 Participants n=50 Participants	140 Participants n=152 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants	1 Participants n=51 Participants	0 Participants n=50 Participants	1 Participants n=152 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=51 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	0 Participants n=152 Participants
Race (NIH/OMB) Asian	0 Participants n=51 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	0 Participants n=152 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=51 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	1 Participants n=152 Participants
Race (NIH/OMB) Black or African American	0 Participants n=51 Participants	1 Participants n=51 Participants	2 Participants n=50 Participants	3 Participants n=152 Participants
Race (NIH/OMB) White	50 Participants n=51 Participants	49 Participants n=51 Participants	47 Participants n=50 Participants	146 Participants n=152 Participants
Race (NIH/OMB) More than one race	0 Participants n=51 Participants	1 Participants n=51 Participants	1 Participants n=50 Participants	2 Participants n=152 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	0 Participants n=152 Participants
Height	165.77 cm STANDARD_DEVIATION 9.143 • n=50 Participants • Two subjects-one in the CT1812 100 mg arm and one in the CT1812 300 mg arm-missed the baseline height measurement.	165.88 cm STANDARD_DEVIATION 11.802 • n=50 Participants • Two subjects-one in the CT1812 100 mg arm and one in the CT1812 300 mg arm-missed the baseline height measurement.	167.52 cm STANDARD_DEVIATION 9.998 • n=50 Participants • Two subjects-one in the CT1812 100 mg arm and one in the CT1812 300 mg arm-missed the baseline height measurement.	166.39 cm STANDARD_DEVIATION 10.335 • n=150 Participants • Two subjects-one in the CT1812 100 mg arm and one in the CT1812 300 mg arm-missed the baseline height measurement.
Weight	72.01 Kg STANDARD_DEVIATION 15.105 • n=51 Participants	67.85 Kg STANDARD_DEVIATION 13.268 • n=51 Participants	68.10 Kg STANDARD_DEVIATION 12.672 • n=50 Participants	69.33 Kg STANDARD_DEVIATION 13.770 • n=152 Participants
BMI	26.04 kg/m^2 STANDARD_DEVIATION 4.574 • n=50 Participants • Two subjects-one in the CT1812 100 mg arm and one in the CT1812 300 mg arm-missed the baseline BMI measurement.	24.43 kg/m^2 STANDARD_DEVIATION 3.554 • n=50 Participants • Two subjects-one in the CT1812 100 mg arm and one in the CT1812 300 mg arm-missed the baseline BMI measurement.	24.13 kg/m^2 STANDARD_DEVIATION 3.046 • n=50 Participants • Two subjects-one in the CT1812 100 mg arm and one in the CT1812 300 mg arm-missed the baseline BMI measurement.	24.87 kg/m^2 STANDARD_DEVIATION 3.846 • n=150 Participants • Two subjects-one in the CT1812 100 mg arm and one in the CT1812 300 mg arm-missed the baseline BMI measurement.

PRIMARY outcome

Timeframe: Up to 210 Days

Population: Data are based on the safety population, which is defined as all participants who received one or more doses of the study drug.

Outcome measures

Outcome measures
Measure	Active Treatment- CT1812 100 mg n=51 Participants CT1812 at a dose of 100 mg CT1812: Active Study Drug	Active Treatment- CT1812 300 mg n=51 Participants CT1812 at a dose of 300 mg CT1812: Active Study Drug	Placebo Comparator - Placebo n=50 Participants Placebo Placebo: Non-active study drug
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs) All TEAEs	36 Participants	42 Participants	39 Participants
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs) Mild TEAEs	19 Participants	22 Participants	22 Participants
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs) Moderate TEAEs	16 Participants	16 Participants	14 Participants
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs) Severe TEAEs	1 Participants	4 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to 210 Days

Population: Data are based on the safety population, which is defined as all participants who received one or more doses of the study drug.

Outcome measures

Outcome measures
Measure	Active Treatment- CT1812 100 mg n=51 Participants CT1812 at a dose of 100 mg CT1812: Active Study Drug	Active Treatment- CT1812 300 mg n=51 Participants CT1812 at a dose of 300 mg CT1812: Active Study Drug	Placebo Comparator - Placebo n=50 Participants Placebo Placebo: Non-active study drug
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs). Participants with at least one TEAE	36 Participants	42 Participants	39 Participants
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs). Participants with at least one TEAE related to treatment	11 Participants	16 Participants	7 Participants
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs). Participants with a TEAE leading to study drug discontinuation	0 Participants	11 Participants	3 Participants
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs). Participants with a TEAE leading to death	0 Participants	0 Participants	1 Participants
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs). Participants with at least one SAE	2 Participants	3 Participants	5 Participants
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs). Participants with at least one SAE related to treatment	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Day 182

Population: The analyzed population represents the number of subjects in the Efficacy modified intent-to-treat (mITT) population and participants who had both baseline and Day 182 CSF samples collected.

Change from baseline in CSF-Aβ, Tau, phospho-Tau, neurogranin, synaptotagmin, synaptosomal-associated protein-25 (SNAP25), neurofilament light chain (NfL), and Aβ-oligomers.Change from baseline is calculated as the observed value minus the baseline value.

Outcome measures

Outcome measures
Measure	Active Treatment- CT1812 100 mg n=51 Participants CT1812 at a dose of 100 mg CT1812: Active Study Drug	Active Treatment- CT1812 300 mg n=50 Participants CT1812 at a dose of 300 mg CT1812: Active Study Drug	Placebo Comparator - Placebo n=49 Participants Placebo Placebo: Non-active study drug
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Alpha Synuclein Protein (ASYNP) (ng/L) - Concentration change in CSF from Baseline to Day 182	48.6 ng/L Standard Deviation 625.13	38.3 ng/L Standard Deviation 213.10	-831.2 ng/L Standard Deviation 3056.97
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Amyloid Beta 1-40 (Aβ40) (ng/L) -Concentration change in CSF from Baseline to Day 182	-573.9 ng/L Standard Deviation 2228.80	-1076.7 ng/L Standard Deviation 1781.36	-17.9 ng/L Standard Deviation 1633.79
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Amyloid Beta 1-42 (Aβ42) (ng/L) -Concentration change in CSF from Baseline to Day 182	-13.5 ng/L Standard Deviation 105.66	-72.1 ng/L Standard Deviation 121.62	3.1 ng/L Standard Deviation 90.90
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Glial Fibrillary Acidic Protein (GFAP) (ng/L) - Concentration change in CSF from Baseline to Day 182	-81.9 ng/L Standard Deviation 457.85	-87.4 ng/L Standard Deviation 176.01	-69.1 ng/L Standard Deviation 321.21
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Neurofilament Light Chain Protein (NFLP) (ng/L) Concentration change in CSF from Baseline to Day 182	72.8 ng/L Standard Deviation 317.59	-55.5 ng/L Standard Deviation 262.24	297.7 ng/L Standard Deviation 535.60
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Neurogranin (NRGR) (ng/L) - Concentration change in CSF from Baseline to Day 182	19.70 ng/L Standard Deviation 82.557	-22.77 ng/L Standard Deviation 68.348	-16.93 ng/L Standard Deviation 44.348
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Phosphorylated Tau Protein 181 (pTau181) (ng/L) Concentration change in CSF from Baseline to Day 182	-0.74 ng/L Standard Deviation 37.227	-9.76 ng/L Standard Deviation 45.506	-4.03 ng/L Standard Deviation 13.185
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Synaptosomal-Associated Protein 25 (SNAP25) Concentration change in CSF from Baseline to Day 182	-0.88 ng/L Standard Deviation 6.485	-1.64 ng/L Standard Deviation 4.767	-1.04 ng/L Standard Deviation 3.763
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Synaptotagmin (SYN) Concentration change in CSF from Baseline to Day 182	0.75 ng/L Standard Deviation 15.041	-19.44 ng/L Standard Deviation 98.693	4.66 ng/L Standard Deviation 56.365
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers Tau Protein (TPROT) (ng/L) Concentration change in CSF from Baseline to Day 182	-8.4 ng/L Standard Deviation 204.92	-47.8 ng/L Standard Deviation 358.68	-9.4 ng/L Standard Deviation 80.67

SECONDARY outcome

Timeframe: Baseline to Day 182

Ratio of Amyloid Beta 1-42 (Aβ42) to Amyloid Beta 1-40 (Aβ40) Concentration from Baseline to Day 182.

Outcome measures

Outcome measures
Measure	Active Treatment- CT1812 100 mg n=51 Participants CT1812 at a dose of 100 mg CT1812: Active Study Drug	Active Treatment- CT1812 300 mg n=50 Participants CT1812 at a dose of 300 mg CT1812: Active Study Drug	Placebo Comparator - Placebo n=49 Participants Placebo Placebo: Non-active study drug
Amyloid Beta 1-42/Amyloid Beta 1-40 (Aβ42/40) in the Cerebrospinal Fluid (CSF) Biomarkers	0.019 ratio Standard Deviation 0.0766	-0.024 ratio Standard Deviation 0.0631	-0.002 ratio Standard Deviation 0.0594

Adverse Events

Active Treatment- CT1812 100 mg

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Active Treatment- CT1812 300 mg

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Placebo Comparator - Placebo

Serious events: 5 serious events

Other events: 33 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Active Treatment- CT1812 100 mg n=51 participants at risk CT1812 at a dose of 100 mg CT1812: Active Study Drug	Active Treatment- CT1812 300 mg n=51 participants at risk CT1812 at a dose of 300 mg CT1812: Active Study Drug	Placebo Comparator - Placebo n=50 participants at risk Placebo Placebo: Non-active study drug
Investigations Alanine aminotransferase increased	0.00% 0/51 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	5.9% 3/51 • Number of events 3 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	0.00% 0/50 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Infections and infestations Nasopharyngitis	0.00% 0/51 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	5.9% 3/51 • Number of events 3 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	8.0% 4/50 • Number of events 4 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Infections and infestations Upper respiratory tract infection	3.9% 2/51 • Number of events 2 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	3.9% 2/51 • Number of events 2 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	6.0% 3/50 • Number of events 3 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Infections and infestations Urinary tract infection	5.9% 3/51 • Number of events 3 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	15.7% 8/51 • Number of events 8 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	10.0% 5/50 • Number of events 6 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Injury, poisoning and procedural complications Fall	13.7% 7/51 • Number of events 10 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	3.9% 2/51 • Number of events 2 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	8.0% 4/50 • Number of events 5 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Injury, poisoning and procedural complications Post lumbar puncture syndrome	3.9% 2/51 • Number of events 2 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	0.00% 0/51 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	8.0% 4/50 • Number of events 4 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Injury, poisoning and procedural complications Skin laceration	5.9% 3/51 • Number of events 3 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	0.00% 0/51 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	0.00% 0/50 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Investigations Hepatic enzyme increased	0.00% 0/51 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	5.9% 3/51 • Number of events 3 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	0.00% 0/50 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Musculoskeletal and connective tissue disorders Arthralgia	7.8% 4/51 • Number of events 4 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	2.0% 1/51 • Number of events 1 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	8.0% 4/50 • Number of events 5 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Nervous system disorders Headache	7.8% 4/51 • Number of events 4 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	0.00% 0/51 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	14.0% 7/50 • Number of events 7 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Psychiatric disorders Anxiety	0.00% 0/51 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	5.9% 3/51 • Number of events 3 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	4.0% 2/50 • Number of events 2 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).
Investigations Blood potassium increased	0.00% 0/51 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	5.9% 3/51 • Number of events 3 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).	4.0% 2/50 • Number of events 2 • Adverse events were captured from the start of study-related procedures at Visit 1 (- 60 to -1 days) until the safety follow up visit V15 (study day 210 (±2) days). Important medical events and conditions occurring prior to this period were not recorded as AEs; they were captured within the medical chart and in the medical history section of the CRF. The safety of CT1812 was evaluated by the incidence and severity of adverse events (AEs) and changes in the usage of concomitant medications, vital signs, physical examination findings, electrocardiogram (ECG) findings, clinical laboratory testing (serum chemistry, hematology, and urinalysis), and Columbia-Suicide Severity Rating Scale (C-SSRS).

Additional Information

Dr. Anthony Caggiano

Cogntion Therapeutics Inc

Phone: 914-221-6730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER