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NCT01747213 · ClinicalTrials.gov registry record · Phase 1
Bisnorcymserine in Healthy Adult Volunteers
A Phase 1 study, sponsored by National Institute on Aging (NIA).
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT01747213: Completed Phase 1 study, sponsored by National Institute on Aging (NIA).
NCT01747213 is a Phase 1 study that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01747213, a Phase 1 study, has completed, sponsored by National Institute on Aging (NIA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
Background: \- Alzheimer s disease (AD) is a brain disease that impairs memory, cognitive abilities and the ability to function independently. It is the most common cause of dementia in older people. It is caused by abnormal proteins in the brain that affect how neurons communicate with each other. Researchers are looking for drugs that can slow down the disease or treat its symptoms. One drug, called bisnorcymserine (BNC), may help improve brain function and symptoms in people with AD. BNC is designed to block a chemical that affects how neurons communicate with each other. Researchers want to see how BNC works in healthy older volunteers. Objectives: \- To look at how the body processes bisnorcymserine taken by mouth and how safe it is for healthy older volunteers. Eligibility: \- Healthy volunteers at least 55 years of age. Design: * Participants will be screened with a physical exam, medical history, and blood and urine tests. * Within 3 weeks from the screening visit, participants will come to the National Institute on Aging clinical unit for a 2-night stay. On the morning of the second day, they will take either a BNC capsule or a placebo. They will not know which tablet they are taking. * Blood samples will be collected frequently throughout the second and third days of the study visit. The last blood sample will be collected about 32 hours after taking the study capsule. Participants will have heart function tests and other exams during the visit. Once the tests are done, they will leave the clinical center. * Participants will have a final follow-up visit about 1 week after leaving the clinical center.
Primary Outcome
Safety and tolerability will be determined based on the frequency of AEs of any grade in BNC and placebo groups. AEs will be determined based on clinical symptoms and signs, vital signs, safety laboratory tests, EKG and continuous cardiac monitoring, MMSE, and C-SSRS.
Interventions
- OTHER Placebo
- DRUG BNC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2013-01-29 |
| Est. Completion | 2019-01-08 |
| Phase | Phase 1 |
What the finished NCT01747213 record still lists
NCT01747213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01747213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01747213 about?
NCT01747213 is a clinical study titled "Bisnorcymserine in Healthy Adult Volunteers". Background: \- Alzheimer s disease (AD) is a brain disease that impairs memory, cognitive abilities and the ability to function independently. It is the most common cause of dementia in older people. It is caused by abnormal proteins in the brain that affect how neurons communicate with each other....
What is the current status of trial NCT01747213?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2013-01-29. Estimated completion is 2019-01-08.
What interventions are being tested in trial NCT01747213?
The interventions under investigation include: Placebo (OTHER), BNC (DRUG).
Who is sponsoring clinical trial NCT01747213?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01747213's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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