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COR388 in Healthy Volunteers and People with Alzheimer's

Start: March 6, 2018
End: October 15, 2018
Enrollment: 36

What Is This Study About?

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.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 80 Years

Must have:

  • 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

Must NOT have:

  • 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

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

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?

Who Sponsors This Study?

Lead: Cortexyme Inc.

Source: ClinicalTrials.gov ID: NCT03418688