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Bisnorcymserine in Healthy Adult Volunteers

Start: November 2012
End: January 8, 2019
Enrollment: 200

What Is This Study About?

The experimental drug bisnorcymserine (BNC) may help improve brain function and symptoms in people with Alzheimer's by blocking a chemical that affects how nerve cells in the brain communicate with each other. Researchers want to see how BNC works and whether it is safe in healthy older volunteers.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: N/A

Must have:

  • Women of childbearing potential must use adequate contraception (such as condoms with spermicide) to avoid pregnancy during the study and for 30 days after taking the study drug; must have a negative urine pregnancy test at screening
  • Men must use adequate contraception (such as condoms with spermicide) to avoid conception during the study and for 30 days after taking the study drug
  • Body mass index (BMI) of 18.5 to 34.0, inclusive; total body weight of more than 110 pounds
  • Good general health as determined by medical history, baseline physical examination, vital signs, clinical laboratory tests, and electrocardiogram (EKG)
  • Participants may have common age-related disorders such as hypertension, diabetes, dyslipidemia, or hypothyroidism as long as these disorders are controlled by diet or medication with a stable medication regimen for at least 2 months

Must NOT have:

  • If female, pregnant or lactating
  • Positive urine test for drugs of abuse at screening
  • Out-of range lab test results deemed clinically significant by the Principal Investigator; any clinically significant abnormality on screening EKG (such as heart block, conduction disorders, ventricular and/or atrial arrhythmias)
  • Systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50-90 mmHg, taken while lying down, on two consecutive measurements taken up to 10 minutes apart
  • Pulse rate greater than 100 bpm or less than 50 bpm, taken while lying down, on two consecutive measurements taken up to 10 minutes apart
  • Alcohol consumption within 48 hours of any study-related activities and during the entire study
  • Tobacco use during the past 12 months
  • History of significant drug allergy or systemic allergic disease (such as urticaria, atopic dermatitis)
  • HIV, hepatitis B, or hepatitis C
  • Other medical or psychological condition or behavior, including current substance dependence or abuse, that may prevent the participant from completing the study
  • Prohibited vitamin and herbal supplements: omega-3 fatty acids (> 1000 mg/day), vitamin E (> 400 IU/day), ginkgo biloba, ginseng
  • Prohibited medications: insulin; anti-parkinsonian medications (such as sinemet, amantadine, bromocriptine, pergolide, selegiline); typical or atypical neuroleptics; narcotic analgesics, long-acting benzodiazepines, or long-acting barbiturates within 4 weeks prior to screening; short-acting anxiolytics or sedative hypnotics taken more than twice a week within 4 weeks prior to screening; medications with known significant cholinergic or anticholinergic side effects (such as pyridostigmine, tricyclic antidepressants, meclizine, oxybutynin) within 4 weeks prior to screening; anticonvulsants (such as phenytoin, phenobarbital, carbamazepine) within 2 months prior to screening; medications for Alzheimer's disease (such as donepezil or memantine); beta-blockers; systemic corticosteroids; neuromuscular-blocking agents; succinylcholine; any other drug that would, in the opinion of the Principal Investigator, pose a risk to the subject or produce overlapping side effects with the study medication
  • Donation or loss of 400 mL or more of blood within 56 days prior to and subsequent to screening
  • Participation in another research study involving an investigational drug within 30 days or 5 half-lives, whichever is longer
  • Known allergy or hypersensitivity to the investigational study drug or placebo components

If I Qualify, Who Do I Contact?

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

 

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: National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT01747213