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A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease

Primary Purpose

Early Alzheimer's Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CT1812
Placebo
Sponsored by
Cognition Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Alzheimer's Disease focused on measuring Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Documentation of the participant's informed consent to study procedures (including ApoE genotyping) and for the use of PHI (HIPAA Authorization, if applicable).
  2. Ages 50-85 years.
  3. Persons with female biological sex, must be of non-childbearing potential. Persons with male biological sex who are sexually active must agree to use acceptable contraceptives during the trial and for 3 months after their last dose unless their partner is using an acceptable means of birth control or is of non-childbearing potential.

    i) Persons with female biological sex will be considered of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age range, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 90 days before Screening). In women under the age of 60, post-menopausal status will be confirmed with follicle stimulating hormone (FSH).

    ii) Persons with male biological sex who are sexually active with a female of child-bearing potential must agree to use condoms during the trial and for 3 months after the last dose unless the female is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condoms, diaphragm, sponge, and cervical cap.

  4. Ability to swallow CT1812 capsules.
  5. Diagnosis of either MCI due to AD or mild AD dementia, defined as meeting all of the following requirements at screening:

    1. At least 6 months of decline in cognitive function
    2. Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised:

    i. ≤8 for 16 or more years of education

    ii. ≤4 for 8-15 years of education

    iii. ≤2 for 0-7 years of education

    c. Global CDR score of 0.5 (for MCI due to AD) and 0.5 to 1 (for mild AD), where Memory Box score ≥0.5.

  6. MMSE 20-30 (inclusive).
  7. Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
  8. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.
  9. Stable dose of permitted medications for 30 days prior to screening.
  10. Resides at home or in the community (assisted living acceptable).
  11. In the opinion of the site PI, has a study partner able and willing to provide accurate information about the participant, oversee the administration of study drug, and participate in study visits and informant-based assessments (usually requires at least 5 hours of contact per week).
  12. As assessed by the site PI, participant is likely to be able to comply with the protocol, including completion of all screening evaluations, and has adequate vision, hearing (hearing aid permitted), and literacy in English or Spanish sufficient for compliance with required testing procedures.

13 Must complete all screening evaluations as outlined in the Schedule of Activities (SoA).

Exclusion Criteria:

  1. Prior or current treatment with a prohibited medication.
  2. Prior treatment with CT1812. NOTE: If a participant was previously involved in a CT1812 study, inclusion in this study is permitted only if it can be confirmed the participant received placebo in the previous CT1812 study.
  3. Enrollment in another investigational study or intake of investigational drug within the previous 30 days or five half lives of the investigational drug, whichever is longer.
  4. Suspected or known allergic reactions, adverse reactions, or hypersensitivity to any components of the study treatments (CT1812 or placebo).
  5. Hospitalization within 30 days prior to screening or baseline.
  6. For participants undergoing an LP for eligibility purposes or as part of the optional longitudinal CSF biomarker sub-study, contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; international normalized ratio (INR) > 1.4 or other coagulopathy; platelet count of < 120,000/μL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of LP (Note: low dose aspirin is permitted); degenerative arthritis of the lumbar spine; suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.
  7. Screening MRI of the brain indicative of significant abnormality, including, but not limited to, prior lobar hemorrhage or infarct >1 cm3, >3 lacunar infarcts, cerebral contusion or encephalomalacia >1 cm, aneurysm, high flow vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or intraaxial brain tumor).
  8. Clinically significant abnormalities in screening laboratory tests, including, but not limited to:

    1. hematocrit less than 35% for those with male biological sex and less than 32% for those with female biological sex
    2. absolute neutrophil cell count of 1500/uL (with the exception of a chronic benign neutropenia)
    3. absolute lymphocyte count <900/uL,
    4. platelet cell count of <120000/uL
    5. INR >1.4 or other coagulopathy, confirmed by repeat
  9. Clinical or laboratory findings consistent with:

    1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
    2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
    3. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
  10. Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as:

    1. Chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, alkaline phosphatase > 1.5 ULN, lactate dehydrogenase (LDH) > 1.5 x ULN).
    2. Respiratory insufficiency.
    3. Renal insufficiency eGFR < 50 mL/min based on the CKD-EPI formula, https://www.mdcalc.com/ckd-epi-equations-glomerular-filtration-rate-gfr
    4. Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening).
    5. Bradycardia (<50/min.) or tachycardia (>100/min.).
    6. Poorly managed hypertension (systolic >160 mm Hg and/or diastolic >95 mm Hg) or hypotension (systolic <90 mm Hg and/or diastolic <60 mm Hg).
    7. Uncontrolled diabetes defined by HbA1c >7.5.
  11. History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.
  12. Seropositive for human immunodeficiency virus (HIV).
  13. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody).
  14. Suspected or known drug or alcohol abuse
  15. A current DSM-V diagnosis of active major depression or GDS > 6, (unless the site PI does not consider participant clinically depressed), schizophrenia, or bipolar disorder.

    NOTE: Participants with depressive symptoms successfully managed by a stable dose of an antidepressant are considered eligible.

  16. Any condition, which in the opinion of the site PI, Data and Coordinating Center, regulatory sponsor, or Protocol PI, makes the participant unsuitable for inclusion.

Sites / Locations

  • Sanders-Brown Center on AgingRecruiting
  • Wake Forest University Health SciencesRecruiting
  • Butler HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

CT1812 100 mg

CT1812 200 mg

Placebo

Arm Description

CT1812 at a dose of 100 n=180 group

CT1812 at a dose of 300mg, n=180 group

Placebo, n=180 group

Outcomes

Primary Outcome Measures

Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
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.

Secondary Outcome Measures

Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 18 months.
Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI at 18 months.
Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.
Change from baseline at 18 months.
Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL)
Change from baseline at 18 months.
Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change
Change from baseline at 18 months.

Full Information

First Posted
August 8, 2022
Last Updated
September 14, 2023
Sponsor
Cognition Therapeutics
Collaborators
National Institute on Aging (NIA), Alzheimer's Clinical Trials Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT05531656
Brief Title
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
Official Title
Synaptic Therapy Alzheimer's Research Trial (START): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease Over 18 Months.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cognition Therapeutics
Collaborators
National Institute on Aging (NIA), Alzheimer's Clinical Trials Consortium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.
Detailed Description
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo for approximately 18 months (72 weeks) in approximately 540 participants diagnosed with early Alzheimer's disease Participants will be randomized 1:1:1 to receive either 100mg or 200mg of CT1812 or placebo. CT1812 or placebo will be administered as 2 capsules to be taken orally once daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Alzheimer's Disease
Keywords
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT1812 100 mg
Arm Type
Active Comparator
Arm Description
CT1812 at a dose of 100 n=180 group
Arm Title
CT1812 200 mg
Arm Type
Active Comparator
Arm Description
CT1812 at a dose of 300mg, n=180 group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, n=180 group
Intervention Type
Drug
Intervention Name(s)
CT1812
Other Intervention Name(s)
Study Drug Active
Intervention Description
Study Drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo
Intervention Description
Non-active study drug
Primary Outcome Measure Information:
Title
Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)
Description
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 18 months.
Time Frame
18 months
Title
Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.
Description
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI at 18 months.
Time Frame
18 months
Title
Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.
Description
Change from baseline at 18 months.
Time Frame
18 months
Title
Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL)
Description
Change from baseline at 18 months.
Time Frame
18 months
Title
Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change
Description
Change from baseline at 18 months.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 50-85 years. Diagnosis of either MCI due to AD or mild AD dementia. MMSE 20-30 (inclusive). Amyloid PET scan of the brain or CSF biomarkers consistent with AD. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read. Exclusion Criteria: Screening MRI of the brain indicative of significant abnormality. Clinically significant abnormalities in screening laboratory tests. Clinical or laboratory findings consistent with: Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.). Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.). Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.) A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor. A current DSM-V diagnosis of active major depression or GDS > 6, schizophrenia, or bipolar disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Executive Assistant
Phone
4124812210
Email
clinicaltrials@cogrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Caggiano, MD
Organizational Affiliation
Cognition Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Sanders-Brown Center on Aging
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Jicha, MD, PhD
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Craft
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Riddle

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease

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