Bisnorcymserine in Healthy Adult Volunteers
Bisnorcymserine in Healthy Adult Volunteers
Overall Status:
Not yet recruiting
Brief Description:
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.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | N/A | Both | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Detailed Description:
In Alzheimer's disease, abnormal protein deposits in the brain cause neurons to lose their ability to communicate with each other effectively and, eventually, to die. Communication between neurons uses chemicals called neurotransmitters, including acetylcholine. Damage to acetylcholine production in the brain is associated with the cognitive and functional deficits of Alzheimer's disease. Stopping or blocking this damage—by inhibiting certain brain enzymes—is one way to treat the symptoms of Alzheimer's. In this study, investigators will test a novel drug, bisnorcymserine (BNC), for the first time in humans. BNC blocks an enzyme, butyrylcholinesterase, and affects how neurons communicate with each other.
Participants will take either BNC (in one of six doses being tested) or a placebo. They will stay in the NIA clinical research unit for 32 hours and return for a follow-up visit to assess safety after about 7 days. A Data Safety Monitoring Board will evaluate the safety and tolerability of each dose before the next higher dose is tested.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 39.2713976, -76.5603828 | Baltimore | Maryland | 21224 | Not yet recruiting | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
National Institute on Aging (NIA) |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Dimitrios I. Kapogiannis, MD | Principal Investigator | National Institute on Aging (NIA) |
Study Contact:
| Name | Phone | |
|---|---|---|
Dimitrios I. Kapogiannis, MD | (301) 451-9286 |
Locations
ClinicalTrials.gov ID
NCT01747213 (follow link to view full record on ct.gov in new window)
Official Title:
Phase I, Double-Blind, Placebo-Controlled, Ascending, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of Bisnorcymserine (BNC), a Highly Selective Inhibitor of Butyrylcholinesterase, in Healthy Adult Volunteers
Study Start Date:
November 2012
Study End Date:
December 2013
Enrollment:
200
Trial References:
