Bisnorcymserine in Healthy Adult Volunteers (NCT01747213) | Clinical Trial Compass
CompletedPhase 1
Bisnorcymserine in Healthy Adult Volunteers
United States75 participantsStarted 2013-01-29
Plain-language 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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Age greater than or equal to 55 years.
* Mini Mental State Examination (MMSE) \> 27 at screening and at Visit 2-Day 1.
* Women who are able to become pregnant must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) at screening and prior to study drug administration
* Both men who are able to father children and women of childbearing potential must be willing to use an adequate method of contraception (see section 7) to avoid conception throughout the study and for up to 30 days of study drug administration.
* Body mass index (BMI) of 18.5 to 34.0, inclusive, and a total body weight of \> 50 kg (110 pounds).
* Participants should be in good general physical and mental health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (EKG). Participants may have common age-related disorders (such as hypertension, type II diabetes, dyslipidemia, hypothyroidism) as long as these disorders are under good control by diet or medications.
* Able to sign own consent
EXCLUSION CRITERIA:
* Any clinically significant medical and psychiatric condition (including asthma active within the last 10 years or COPD, and drug abuse and dependency).
* Subject has used any tobacco products in the past 3 months.
* A history of significant allergy to any drug or systemic allergic disease (e.g., urticaria, atopic dermatitis).
* Pregnant or lactating females.
* Subj…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 1 trial in healthy volunteers focused on safety and tolerability — what does that mean in terms of how much is actually known about whether bisnorcymserine works for treating any condition I might have?
2Since this trial has already been completed, would my doctor be able to find out what the safety results showed, and whether any concerning side effects were identified in the healthy volunteers who participated?
3If bisnorcymserine is still in early-stage testing and was only studied in healthy people so far, does that mean there are later-phase trials ongoing that might be more relevant for me to look into?
4Given that Phase 1 trials are primarily designed to test safety rather than effectiveness, should I be focusing my energy on exploring treatments that already have more established evidence behind them?
5Is there a way to find out whether the researchers who ran this trial have published their findings, so my doctor and I can review what the safety and tolerability data actually showed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.