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COR388 in Healthy Volunteers and People with Alzheimer's

Completed

This Phase 1 study will assess the safety and tolerability of the investigational drug COR388 in healthy older adults and older adults with Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 80 Years All Yes
March 6, 2018
October 15, 2018
36

  • Not breastfeeding or pregnant
  • Agree to use contraception or avoid intercourse from first day to 90 days after dosing for males and from 10 days before to 28 days after dosing for females
  • Medications for chronic illnesses must be stable for 30 days, with no changes expected during study
  • Body mass index of 19 to 35
  • Good general health as determined by medical history, physical exam, laboratory reports, and electrocardiogram (ECG)
  • Non-smoker and non-tobacco user for at least 6 months before and during study
  • Able to swallow capsules
  • Able to read and understand English

Participants with Alzheimer's

  • Probable Alzheimer's disease
  • Mini-Mental State Examination score of 14 to 25
  • Moderate to severe periodontitis (an infection that affects the gums and bones that support the teeth) as determined by a dentist during screening
  • If applicable, have a primary caregiver to administer study drug and assess participants' condition throughout the study
  • If not able to provide written informed consent, legally authorized representative must provide written consent and participant may provide verbal consent; if the participant has a caregiver, the caregiver must provide written informed consent

  • History or current evidence of arrhythmia (irregular heartbeat), heart failure, low blood pressure, or liver disease
  • Evidence of poor kidney function (estimated glomerular filtration rate less than 50 mL/min/1.73m2)
  • Treated for periodontitis in the last 90 days, including antibiotics, scaling, root planing, or other surgical treatments
  • Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke
  • Systemic infection in last 30 days that required antibiotics for longer than 1 week
  • History or current evidence of psychiatric or emotional problems that could interfere with study participation
  • History of systemic allergic reaction to any drug that is considered significant by the investigator
  • History of alcohol or drug abuse or dependence within past 12 months
  • Positive screen for alcohol, prohibited drugs, human immunodeficiency virus (1 and 2), hepatitis B, or hepatitis C
  • Any conditions that could interfere with participation in or completion of the study or with study results
  • Abnormal results of screening laboratory tests, ECG, or magnetic resonance imaging of the brain
  • Use of any prohibited medication that cannot be stopped or replaced safely
  • Participation in another investigational small molecule drug study within 30 days or biological drug study within 60 days prior to dosing

Participants will be randomly assigned to take either increasing doses of COR388 or placebo for 10 to 28 days. COR388 is a bacterial protease inhibitor that targets a pathogen identified in brain tissue and cerebral spinal fluid of people with Alzheimers disease and is being studied as a possible treatment for Alzheimer's. Researchers will collect blood samples to measure pharmacokinetics.

For more information about this trial or study sites, call 404-819-3726 or email clinicaltrials@cortexyme.com.

Name City State Zip Status Primary Contact
Pacific Research Network
San Diego California 92103

Bioclinica Research
Orlando Florida 32806

Medpace Clinical Pharmacology Unit
Cincinnati Ohio 45227

Cortexyme Inc.

Name Phone Email
Samer Kaba, MD 404-819-3726 clinicaltrials@cortexyme.com

NCT03418688

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease