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30mg Buntanetap for Alzheimer's Disease

Homestead Associates in Research, Inc, Miami, FL
Alzheimer's DiseaseBuntanetap - Drug
Eligibility
55 - 85
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2 & 3

Similar Trials

1
Group 1
1
MK-1942 15 mg
1
RO7126209

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Screening (up to 42 days) through end of treatment period (12 weeks) for a total of up to 4.2 months

Week 12
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change
Week 12
Digital Symbol Substitution Test
Week 12
Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale
Week 12
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11
Month 2
Mini Mental State Examination Score

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Group 1
2
MK-1942 15 mg
1
RO7126209

Side Effects for

Posiphen, 40mg (Parkinson's Participants)
10%constipation
10%post lumbar puncture syndrome
10%paraesthesia
10%erythema
10%headache
10%procedural headache
10%back pain
This histogram enumerates side effects from a completed 2022 Phase 1 & 2 trial (NCT04524351) in the Posiphen, 40mg (Parkinson's Participants) ARM group. Side effects include: constipation with 10%, post lumbar puncture syndrome with 10%, paraesthesia with 10%, erythema with 10%, headache with 10%.

Trial Design

4 Treatment Groups

30mg Buntanetap
1 of 4
7.5mg Buntanetap
1 of 4
15mg Buntanetap
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

320 Total Participants · 4 Treatment Groups

Primary Treatment: 30mg Buntanetap · Has Placebo Group · Phase 2 & 3

30mg Buntanetap
Drug
Experimental Group · 1 Intervention: Buntanetap · Intervention Types: Drug
7.5mg Buntanetap
Drug
Experimental Group · 1 Intervention: Buntanetap · Intervention Types: Drug
15mg Buntanetap
Drug
Experimental Group · 1 Intervention: Buntanetap · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: 12 Weeks
Reporting: screening (up to 42 days) through end of treatment period (12 weeks) for a total of up to 4.2 months

Who is running the clinical trial?

Annovis Bio Inc.Lead Sponsor
4 Previous Clinical Trials
548 Total Patients Enrolled

Eligibility Criteria

Age 55 - 85 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are taking cholinesterase inhibitors or memantine medication.
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 are taking medication for epilepsy, mood stabilization or neuropathic pain.
You are taking medication to treat mood disorders, such as lithium.

Who else is applying?

What state do they live in?
New Jersey100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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