ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03507790
Recruitment Status : Not yet recruiting
First Posted : April 25, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Cognition Therapeutics

Brief Summary:
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).

Condition or disease Intervention/treatment Phase
Mild to Moderate Alzheimer's Disease Drug: CT1812 Drug: Placebo Phase 2

Detailed Description:

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).

This Phase 2 study is designed to evaluate the safety of two doses of CT1812 administered once daily for 6 months in adults aged 50 to 85 who have been diagnosed with mild to moderate Alzheimer's disease (the targeted clinical indication for CT1812). Randomized participants will receive 100 mg of CT1812, 300 mg of CT1812, or placebo once daily for 182 days. Exploratory endpoints that evaluate the effect of CT1812 on biomarkers are also included.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multi-center Phase 2, randomized, double-blind, placebo-controlled, parallel-group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
Estimated Study Start Date : July 31, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Treatment- CT1812 100 mg
CT1812 at a dose of 100 n=8 group
Drug: CT1812
Active Study Drug
Other Name: Study Drug

Active Comparator: Active Treatment- CT1812 300 mg
CT1812 at a dose of 300mg, n=8 group
Drug: CT1812
Active Study Drug
Other Name: Study Drug

Placebo Comparator: Placebo Comparator - Placebo
Placebo, n=8 group
Drug: Placebo
Non-active study drug
Other Name: Matching Placebo




Primary Outcome Measures :
  1. To assess the pharmacodynamic effect of CT1812 on CSF biomarker [ Time Frame: 26 weeks ]
    Pharmacodynamic biomarker will be assessed by using CSF- neurogranin



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.

    i) Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If less than 24 months, an serum FSH value confirming post- menopausal status can be employed.

    ii) Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman 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 condom, diaphragm, sponge, and cervical cap.

  2. Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening.
  3. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease and without findings of significant exclusionary abnormalities (see exclusion criteria, number 3).
  4. MMSE 18-26 inclusive.
  5. No active depression and a GDS ≤6 (see exclusion criteria number 5).
  6. Modified Hachinski ≤ 4.
  7. Formal education of eight or more years.
  8. Subjects must have a caregiver/ study partner who in the opinion of the site principal investigator, has contact with the study subject for a sufficient number of hours per week to provide informative responses on the protocol assessments, oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study assessments. The caregiver/ study partner must provide written informed consent to participate in the study.

11) Subjects living at home or in the community (assisted living acceptable). 12) Ability to swallow CT1812 capsules. 13) Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.

14) Subjects must be capable of providing either written informed consent or oral assent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable]. All consent processes must be undertaken in the presence of a witness and prior to any study procedures.

15) Must consent to apolipoprotein E (ApoE) genotyping for data analysis stratification.

16) Subjects shall be generally healthy with mobility (ambulatory or ambulatory-aided, i.e., walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures.

16) Must be able to complete all screening evaluations.

Exclusion Criteria:

  1. Hospitalization (except for planned procedures) or change of chronic concomitant medication within one month prior to screening.
  2. Subjects living in a continuous care nursing facility.
  3. Contraindications to the MRI examination for any reason.
  4. Screening MRI 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).
  5. 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. Seizure disorder.
    4. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
  6. A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Subjects with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry.
  7. Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as:

    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.

  8. Seropositive for human immunodeficiency virus (HIV).
  9. 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).
  10. Clinically significant abnormalities in screening laboratory tests,
  11. Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.).
  12. Women who are fertile and of childbearing potential.
  13. Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents, antiepileptics, centrally active anti-hypertensive drugs
  14. Suspected or known drug or alcohol abuse, i.e. more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day indicated by elevated MCV significantly above normal value at screening.
  15. Suspected or known allergy to any components of the study treatments.
  16. 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.
  17. Intake of drugs or substances potentially involved in clinically significant CYP3A4 or P-gp mediated drug interactions with CT1812, within 4 weeks or five half-lives of the interacting drug prior to administration of CT1812 and throughout the course of the study. Grapefruit juice should be avoided in the two weeks prior to dosing. See Appendix A for a complete list of prohibited substances.
  18. Exposure to immunomodulators, anti Aβ vaccines, passive immunotherapies for AD (e.g. monoclonal antibodies) within the past 180 days and/or exposure to BACE inhibitors within the past 30 days
  19. 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 screening (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.
  20. Any condition, which in the opinion of the investigator or the sponsor makes the subject unsuitable for inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507790


Contacts
Contact: Alyssa Galley 1 617.459.9134 agalley@CogRx.com

Locations
United States, Florida
JEM Research Institute Not yet recruiting
Atlantis, Florida, United States, 33462
Contact: Janet O' Brien, RN       jobrien@jemri.net   
Principal Investigator: Mark Goldstein, MD, CPI         
Albuquerque Neuroscience, Inc Not yet recruiting
Maitland, Florida, United States, 32751
Contact: Amanda Occhino, BS       aocchino@meridienresearch.com   
Principal Investigator: Eva-Maria Heurich, DO, FAAFP, C         
Allied Biomedical Research Institute Not yet recruiting
Miami, Florida, United States, 33155
Contact: Luis Estevez, DPH       lestevez@abriusa.net   
Principal Investigator: Michael Pfeffer, MD         
Compass Research LLC- Bioclinica Research Not yet recruiting
The Villages, Florida, United States, 32162
Contact: Miranda Foster, RN       miranda.foster@bioclinica.com   
Principal Investigator: David Subich, MD, FAPCR, CPI         
United States, New Mexico
Meridien Research- Maitland Outpatient Not yet recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Jose Munoz, BS       jose@albneuro.com   
Principal Investigator: Glenn Dempsey, MD         
Australia, Victoria
Austin Health Not yet recruiting
Ivanhoe, Victoria, Australia, 3079
Contact: Kathy Skoff       Kathy.SKOFF@austin.org.au   
Principal Investigator: Michael Woodward         
St Vincent's Hospital Sydney Not yet recruiting
Ivanhoe, Victoria, Australia, 3079
Contact: Marko Garcia       Marko.Garcia@svha.org.au   
Principal Investigator: Bruce Brew         
Alfred Health Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Lucy Vivash       L.Vivash@alfred.org.au   
Principal Investigator: Terence O'Brien         
Melbourne Health Not yet recruiting
Parkville, Victoria, Australia, 3050
Contact: Lucy Vivash       Lucy.Vivash@mh.org.au   
Principal Investigator: Nawaf Yassi, MD         
Australia, Western Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Cognition Therapeutics
Investigators
Study Director: Alyssa Galley Cognition Therapuetics

Responsible Party: Cognition Therapeutics
ClinicalTrials.gov Identifier: NCT03507790     History of Changes
Other Study ID Numbers: COG0201
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cognition Therapeutics:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders