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Study Summary
This trial will test 3 doses of a drug to see if it is safe & effective for mild-moderate Alzheimer's patients. It'll last 4-5 months with 4 clinic visits & 1 phone call.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 1 & 2 trial • 75 Patients • NCT04524351Trial Design
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- You are allergic to the material used to make the capsule shells called hypromellose.You are allergic to titanium dioxide, which is used to make the capsule shells opaque.I'm sorry, but "Magnesium Stearate" is not a criterion in and of itself. Magnesium stearate is a common ingredient in many medications and supplements, and is generally considered safe for human consumption. It is often used as a lubricant or filler in pills and capsules. If you can provide me with more context, I can try to help you understand how magnesium stearate might be relevant to a specific clinical trial.You are taking cholinesterase inhibitors or memantine medication.You have had a problem with drugs or alcohol that was serious enough to be diagnosed by a doctor in the last 5 years.You have a condition that affects your ability to learn or develop normally.You are allergic to the investigational drug or any of its inactive ingredients.There is an ingredient called silicified microcrystalline cellulose in the study drug.You have not had thoughts of harming yourself or attempted suicide in the past two months or engaged in any suicidal behavior in the past six months, as determined by a medical professional using a standardized scale.You have a history of seizures, but it's okay if you're currently taking medicine and your condition is stable.You are taking medication to treat mood disorders, such as lithium.You have a history of severe mental illnesses such as schizophrenia, bipolar disorder or major depression according to the DSM criteria. However, mild depression that can be managed with a specific type of medication is allowed.You have a type of dementia that is not Alzheimer's disease, such as vascular dementia, Lewy body dementia, frontotemporal disease, Parkinson disease dementia, or dementia caused by vitamin B12 or thyroid deficiency.You have thoughts of hurting yourself or others, or have attempted suicide in the past 6 months.You are taking medication for epilepsy, mood stabilization or neuropathic pain.
- Group 1: 15mg Buntanetap
- Group 2: 7.5mg Buntanetap
- Group 3: 30mg Buntanetap
- Group 4: Placebo
- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this study seeking participation from elderly individuals?
"In accordance with the outlined parameters, individuals between 55 and 85 years old are eligible for enrollment in this clinical trial."
In what number of medical facilities is this experimental protocol being implemented?
"Currently, there are 18 sites offering this medical trial. These include Coral Springs, Daytona Beach and DeLand in addition to other locations around the country. It is beneficial for patients to select a nearby location as it reduces travel needs upon enrollment."
Is this research project open for enrollment at present?
"According to the clinicaltrials.gov portal, this research is still recruiting patients. Initially published on April 1st 2023 and recently revised on July 4th 2023, it requires a total of 100 participants from 3 separate sites."
Is it possible for me to become a participant in this trial?
"This research is seeking 320 individuals affected by Alzheimer's disease between the ages of 55 and 85. To be eligible, one must have a formal diagnosis according to NIA-AA criteria for probable AD; scores on MMSE must fall within 14-24 points range; each participant needs to designate an informed study partner who will accompany them throughout the trial visits and maintain regular contact with the patient (defined as 10 hours per week); certain contraception methods are also mandatory: combined hormonal contraceptives, progestin-only contraceptives, intrauterine devices or systems, bilateral tubal occlusion, vasectomized partners with confirmed absence of sperm in"
How many participants are engaged in this clinical experiment?
"This clinical trial necessitates 320 individuals meeting the designated eligibility requirements to partake. Potential participants can join from The Neurology Institute - Coral Springs in Coral Springs, Florida and Arrow Clinical Trial in Daytona Beach, Georgia among other sites."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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