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BMS-984923 for Alzheimer's Disease
Phase 1
Recruiting
Led By Stephanie Post, MD
Research Sponsored by Allyx Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours after last dose
Awards & highlights
Study Summary
This trial tests a new drug to see if it is safe and well-tolerated by healthy adults and those with Alzheimer's.
Who is the study for?
This trial is for men and women aged 50-80 without cognitive impairment, able to consent and follow study rules. Women must be postmenopausal or unable to have children; men must use condoms if with a woman who can bear children. Participants should score over 25 on the MOCA test.Check my eligibility
What is being tested?
The study tests BMS-984923's safety and tolerability in older adults and Alzheimer's patients by comparing it with a placebo. It involves gradually increasing doses to see how participants respond.See study design
What are the potential side effects?
Since this is an early-phase trial for BMS-984923, specific side effects are being studied but may include typical drug reactions like nausea, headaches, dizziness, or allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours after last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours after last dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stage 1 Incidence of clinically significant changes in safety assessments
Stage 1 and Stage 2 Incidence of clinically significant lab abnormalities
Stage 1 and Stage 2 Incidence of treatment-emergent adverse events (TEAEs)
+1 moreSecondary outcome measures
Stage 1 and Stage 2 Area under the curve for the first 24 hours of dosing (AUC24h) and at steady state as determined by PK modeling
Stage 1 and Stage 2 Trough plasma drug concentration at steady state
Stage 2 Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale 14 Score range of 0-90, with higher scores indicating greater cognitive impairment.
+1 moreSide effects data
From 2022 Phase 1 trial • 36 Patients • NCT0480598317%
Blood pressure increased
17%
Headache
17%
Blood triglycerides increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg BMS-984923
150 mg BMS-984923
40 mg BMS-984923
70 mg BMS-984923
100 mg BMS-984923
200 mg BMS-984923
Trial Design
11Treatment groups
Experimental Treatment
Placebo Group
Group I: 50 mg activeExperimental Treatment1 Intervention
BMS-984923 50 mg in healthy participants
Group II: 50 mg Active-ADExperimental Treatment1 Intervention
BMS-984923 50 mg
Group III: 150 mg Active 20dExperimental Treatment1 Intervention
BMS-984923 150 mg in healthy participants 20 days
Group IV: 100 mg Active-ADExperimental Treatment1 Intervention
BMS-984923 100 mg
Group V: 100 mg Active 20dExperimental Treatment1 Intervention
BMS-984923 100 mg in healthy participants 20 days
Group VI: 100 mg ActiveExperimental Treatment1 Intervention
BMS-984923 100 mg in healthy participants
Group VII: 100 mg Placebo 20dPlacebo Group1 Intervention
Placebo 100 mg in healthy participants 20 days
Group VIII: 150 mg Placebo 20dPlacebo Group1 Intervention
Placebo 150 mg in healthy participants 20 days
Group IX: 50 mg PlaceboPlacebo Group1 Intervention
Placebo 50 mg in healthy participants
Group X: 100 mg PlaceboPlacebo Group1 Intervention
Placebo 100 mg in healthy participants
Group XI: Placebo-ADPlacebo Group1 Intervention
Placebo matching
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-984923
2021
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Allyx TherapeuticsLead Sponsor
2 Previous Clinical Trials
30 Total Patients Enrolled
Yale UniversityOTHER
1,853 Previous Clinical Trials
2,738,511 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,835 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious or unstable health conditions.I have a serious nerve condition.I have been diagnosed with major depression, schizophrenia, or bipolar disorder.I do not have any conditions that affect how drugs are broken down in my body.I have had hepatitis B or C.I am not taking any medications that could interact with the trial drugs.I am taking certain medications for my mental health.I have used blood thinners within the required timeframe.I am between 50 and 80 years old.I am not pregnant, breastfeeding, or able to become pregnant.I am a woman who has been postmenopausal for over 24 months.I agree to use condoms or ensure my partner uses birth control during and for 3 months after the trial.I have a GDS score of 5 or higher and symptoms of major depression.
Research Study Groups:
This trial has the following groups:- Group 1: 100 mg Placebo 20d
- Group 2: 150 mg Placebo 20d
- Group 3: 100 mg Active-AD
- Group 4: 150 mg Active 20d
- Group 5: 50 mg Active-AD
- Group 6: 100 mg Active 20d
- Group 7: 50 mg active
- Group 8: 50 mg Placebo
- Group 9: 100 mg Active
- Group 10: 100 mg Placebo
- Group 11: Placebo-AD
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted approval for a 150 mg dosage of Active-AD?
"The 150 mg Active-AD dose has earned a score of 1 on our scale, which is congruent with its Phase 1 status. This suggests that there are limited data supporting the safety and efficacy of this dosage amount."
Answered by AI
Are elderly patients being excluded from this exploratory research?
"The criteria for participating in this investigation stipulates that patients must be between 50 and 80 years old. Alternatively, there are 19 medical trials designed for people under 18 and 532 available to those over 65."
Answered by AI
Are there still opportunities for enrolment in this experiment?
"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial, first listed on March 28th 2023, is presently recruiting individuals. 50 participants are needed between 2 specific sites."
Answered by AI
To what extent is this trial populated with participants?
"Affirmative. On clinicaltrials.gov, the study is listed as actively recruiting participants since it was initially posted on March 28th 2023 and updated recently on March 27th 2023. Two medical centres are enrolling a total of 50 patients in this experiment."
Answered by AI
What criteria must be met to gain admittance into this medical experiment?
"In order to partake in this trial, participants should have a diagnosis of Alzheimer's and must be within the range of 50-80 years old. The study requires approximately 50 individuals for enrollment."
Answered by AI
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