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

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ClinicalTrials.gov Identifier: NCT03507790
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : April 1, 2019
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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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.
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

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. Number of study participants with treatment related adverse events and serious adverse events [ Time Frame: 210 Days ]
    Adverse events will be collected starting at Day 1 through Day 210 to evaluate safety.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 last natural menses less than 24 months, a 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. Diagnostic confirmation by a CSF sample collected at the screening visit lumbar puncture in place of amyloid PET will also be acceptable
  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 4). An historical MRI, up to 1 year prior to screening, may be used as long as 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.).
  4. MMSE 18-26 inclusive.
  5. No active depression and a GDS ≤6 (see exclusion criteria number 6).
  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.
  9. Subjects living at home or in the community (assisted living acceptable).
  10. Ability to swallow CT1812 capsules.
  11. Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
  12. Subjects must be capable of providing written informed consent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA), if applicable]. Written informed consent also shall be obtained from the responsible caregiver. All consent processes must be undertaken in the presence of a witness and prior to any study procedures.
  13. Must consent to apolipoprotein E (ApoE) genotyping for data analysis stratification.
  14. 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.
  15. Must be able to complete all screening evaluations.

EXCLUSION CRITERIA:

Participants will be excluded from the study if any of the following conditions apply:

  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. Contraindication to the MRI examination for any reason.
  4. Screening MRI (or historical MRI, 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..
  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:

    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.
  8. 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.
  9. Seropositive for human immunodeficiency virus (HIV).
  10. 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).
  11. Clinically significant abnormalities in screening laboratory tests, including:

    a. Hematocrit less than 35% for males and less than 32% for females, absolute neutrophil cell count of 1500/uL (with the exception of a documented history of a chronic benign neutropenia), or platelet cell count of < 120,000/uL; INR >1.4 or other coagulopathy, confirmed by repeat assessment of: i. Hematocrit ii. Neutrophil count iii. Platelet count

  12. Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.).
  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 (e.g., clonidine, l-methyl dopa, guanidine, guanfacine, etc.), sedatives, opioids, mood stabilizers (e.g., valproate, lithium); or benzodiazepines, with the following exception:

    a. Low dose lorazepam may be used for sedation prior to MRI scan for those subjects requiring sedation. At the discretion of the investigator, 0.5 to 1 mg may be given orally prior to scan with a single repeat dose given if the first dose is ineffective. No more than a total of 2 mg lorazepam may be used for the MRI scan.

  14. Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. small bowel disease, Crohn's disease, celiac disease, or liver disease).
  15. Nootropic drugs except stable AD meds (acetylcholinesterase inhibitors and memantine.
  16. 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.
  17. Suspected or known allergy to any components of the study treatments.
  18. 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.
  19. Intake of drugs or substances potentially involved in clinically significant induction or inhibition of 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 and throughout the course of the study. See Appendix A for a complete list of prohibited substances.
  20. 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.
  21. Anticipated use of nonsteroidal anti-inflammatory drugs (NSAIDs) on more than 14 days during the period from Baseline to Day 182.
  22. 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.
  23. 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
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Contact: Alyssa Galley 1 617.459.9134 agalley@CogRx.com

Locations
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United States, Arizona
Imaging Endpoints Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Diana De Santiago       ddesantiago@imagingendpoints.com   
United States, Florida
JEM Research Institute Recruiting
Atlantis, Florida, United States, 33462
Contact: Janet O' Brien, RN       jobrien@jemri.net   
Principal Investigator: Mark Goldstein, MD, CPI         
Meridien Research Inc. 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 Recruiting
Miami, Florida, United States, 33155
Contact: Luis Estevez, DPH       lestevez@abriusa.net   
Principal Investigator: Michael Pfeffer, MD         
Compass Research LLC- Bioclinica Research Recruiting
The Villages, Florida, United States, 32162
Contact: Miranda Foster, RN       miranda.foster@bioclinica.com   
Principal Investigator: David Subich, MD, FAPCR, CPI         
United States, North Carolina
Alzheimer's Memory Center Recruiting
Charlotte, North Carolina, United States, 28270
Contact: Jessica Porto       jporto@amcneurology.com   
Principal Investigator: Mohammad Bolouri, MD         
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Beth Harders       elhard@pennmedicine.upenn.edu   
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 Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Paula Mather       paula.mather@alzheimers.com.au   
Principal Investigator: Roger Clarnette         
Sponsors and Collaborators
Cognition Therapeutics
Investigators
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Study Director: Alyssa Galley Cognition Therapuetics

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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: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders