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CT1812 for Mild to Moderate Alzheimer's Disease

Start: October 2, 2018
End: October 24, 2023
Enrollment: 120

What Is This Study About?

This Phase II trial will study the safety and efficacy of two different doses of the research drug CT1812 in adults with mild to moderate Alzheimer's disease.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 85 Years

Must have:

  • Diagnosis of mild to moderate Alzheimer's disease and at least a six-month decline in cognitive function
  • Non-childbearing potential (postmenopausal or undergone a bilateral tubal ligation or hysterectomy)
  • Males who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for three months after unless using acceptable birth control
  • Evidence of amyloid on positron emission tomography scan done previously or during screening
  • Magnetic resonance imaging (MRI) obtained during screening consistent with Alzheimer's disease diagnosis
  • Mini-Mental State Examination score of 18 to 26
  • Modified Hachinski Ischemia score of 4
  • Eight or more years of education
  • Caregiver/study partner who can provide responses on assessments, oversee study drug administration, and participate in clinic visits
  • Living at home or in the community (assisted living allowed)
  • If taking medications for chronic conditions, must be stable dose for at least 30 days
  • Consent to APOE genotyping
  • Generally healthy with vision, hearing, and mobility sufficient to complete testing (hearing aids and walkers/canes permissible)

Must NOT have:

  • Hospitalization or change of chronic medication within past month
  • Living in a continuous care nursing facility
  • Inability to undergo MRI
  • Brain MRI showing significant abnormality, including prior hemorrhage or infarct greater than one cubic centimeter, more than three lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, or space-occupying lesion
  • Evidence of other primary degenerative dementia or neurodegenerative condition (e.g., dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, Parkinson's disease, or amyotrophic lateral sclerosis)
  • Seizure disorder
  • Other infectious, metabolic, or systemic diseases affecting the central nervous system (e.g., syphilis, hypothyroidism, or vitamin B12 or folate deficiency)
  • Diagnosis of active major depression, schizophrenia, or bipolar disorder (depressive symptoms managed by stable antidepressants are allowed)
  • Cancer within past three years, except fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least six months
  • Seropositive for HIV
  • History of acute/chronic hepatitis B or C and/or carrier of hepatitis B
  • Clinically significant abnormalities in screening laboratory tests
  • Hearing, vision, or language impairments or disability that would interfere with study
  • Use of antipsychotics, antiepileptics, and centrally active anti-hypertensive drugs four weeks before and during the study
  • Drug or alcohol abuse (more than approximately 1 liter of beer or 0.5 liter of wine per day)
  • Allergy to any components of the study treatments
  • Enrollment in another investigational study or intake of investigational drug within past 30 days or five half-lives, whichever is longer
  • Intake of drugs or substances that could interact with CT1812 within four weeks or five half-lives of study administration and throughout the study
  • Intake of grapefruit juice two weeks prior to dosing
  • Exposure to immunomodulators, anti-amyloid vaccines, or passive immunotherapies for Alzheimer's disease (e.g., monoclonal antibodies) within past 180 days or BACE inhibitors within past 30 days
  • Inability to undergo a lumbar puncture, including infection at the desired lumbar puncture site, use of anti-coagulant medication within past 90 days (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, or inability to maintain flexed position during procedure

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Who Is the General Study Contact?

For more information and to enroll, visit the study website.

Study Contact
Jiney Asthappan

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Arizona
21st Century Neurology/ Xenoscience Inc.
Phoenix, AZ 85004
Recruiting
Stephen S Flitman, MD
Imaging Endpoints
Scottsdale, AZ 85258
Recruiting
Diana De Santiago
California
ATP Clinical Research
Costa Mesa, CA 92626-4627
Recruiting
Gustavo Alva, MD
Connecticut
Ki Health Partners
Stamford, CT 06905
Recruiting
Florida
JEM Research Institute
Atlantis, FL 33462
Recruiting
Julie Andrew, RN
Charter Research
Lady Lake, FL 32159
Recruiting
Jeffrey A Norton, MD
ClinCloud
Viera, FL 32940
Recruiting
Rosemary Laird, MD
Massachusetts
ActivMed Practices & Research, LLC
Methuen, MA 01844
Recruiting
Marc Shay, MD
North Carolina
Alzheimer's Memory Center
Charlotte, NC 28270
Recruiting
Jessica Porto
Ohio
The Ohio State University - Wexner
Columbus, OH 43221-3502
Recruiting
Douglas Scharre, MD
Neuro Behavirol Clinical Research C
North Canton, OH 44720
Recruiting
Shiskuka Malhotra, MD
Texas
Gill Neurosciences
Houston, TX 77065
Recruiting

Who Sponsors This Study?

Lead: Cognition Therapeutics

Source: ClinicalTrials.gov ID: NCT03507790