A Phase 1B Multiple Ascending Dose Study of The Safety and Tolerability of BMS-984923 in Healthy Older Adults and Patients With Alzheimer's Disease

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A Phase 1b Multiple Ascending Dose Study of the Safety and Tolerability of BMS-984923 in Healthy Older Adults and Patients with Alzheimer's Disease

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Men or women between the ages of 50 and 80 years, inclusive

• No history of cognitive impairment

• Capable of providing written informed consent and willing to comply with all study requirements and procedures

• Participant is not pregnant, lactating, or of childbearing potential

∙ Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months prior; menopausal status will be documented with serum follicle-stimulating hormone (FSH) or documentation of bilateral tubal ligation or hysterectomy

‣ Male participants who are sexually active with a woman of childbearing potential must agree to use condoms during the trial and for 3 months after the last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap.

‣ Male participants must also agree not to donate sperm for 90 days after the last dose.

• Montreal Cognitive Assessment (MOCA) \>25

• Men or women between the ages of 50 and 85 years, inclusive, at the time of first dose of investigational product (IP).

• Diagnosis of either amnestic mild cognitive impairment (aMCI) or mild dementia due to AD as defined by

‣ Mild dementia due to AD

• National Institute on Aging (NIA)-Alzheimer's Association core clinical criteria for dementia due to probable AD (McKhann 2011) and,

∙ Mini Mental Status Exam (MMSE) score between 18 and 26 (inclusive)

∙ Clinical Dementia Rating (CDR) global score of 0.5 or 1

⁃ aMCI due to AD

• Subjective memory complaint preferably corroborated by an informant and,

∙ Normal activities of daily living

∙ CDR global score of 0.5

∙ aMCI (Petersen 2004) as evidenced by abnormal memory function documented by scoring 1.5 SD below the education adjusted cutoff on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (the maximum score is 25), and

‣ 8 for 16 or more years of education

⁃ 4 for 8 15 years of education

• Stable pharmacological treatment of any other chronic conditions for at least 4 weeks prior to baseline.

• Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of AD as defined in Criteria 2 and without findings of significant exclusionary abnormalities (see Section 6.2.2, exclusion criteria, Number 4).

• Study partner is available who has frequent contact with the participant (e.g., average of 10 hours per week or more), and can participate in all study partner assessments for the duration of the protocol.

• Generally healthy with mobility (ambulatory or ambulatory-aided, i.e., walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures as determined by the PI.

• Must be able to complete all screening evaluations

• Living at home or in the community (assisted living acceptable)

• Ability to swallow study medication.

⁃ Modified Hachinski score ≤4

⁃ Capable of providing written informed consent and willing to comply with all study requirements and procedures

⁃ Participant is not pregnant, lactating, or of childbearing potential

∙ Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months prior; menopausal status will be documented with serum FSH or documentation of bilateral tubal ligation or hysterectomy

‣ Male participants who are sexually active with a woman of childbearing potential must agree to use condoms during the trial and for 3 months after the last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of IUD, male or female condom, diaphragm, sponge, and cervical cap.

‣ Male participants must also agree not to donate sperm for 90 days after the last dose.

Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Wisconsin
Spaulding Clinical Research
ACTIVE_NOT_RECRUITING
West Bend
Contact Information
Primary
Carol Gunnoud
carol.gunnoud@yale.edu
203-764-8100
Time Frame
Start Date: 2023-03-28
Estimated Completion Date: 2025-07-15
Participants
Target number of participants: 50
Treatments
Experimental: 50 mg active
BMS-984923 50 mg in healthy participants
Placebo_comparator: 50 mg Placebo
Placebo 50 mg in healthy participants
Experimental: 100 mg Active
BMS-984923 100 mg in healthy participants
Placebo_comparator: 100 mg Placebo
Placebo 100 mg in healthy participants
Experimental: 100 mg Active 20d
BMS-984923 100 mg in healthy participants 20 days
Placebo_comparator: 100 mg Placebo 20d
Placebo 100 mg in healthy participants 20 days
Experimental: 150 mg Active 20d
BMS-984923 150 mg in healthy participants 20 days
Placebo_comparator: 150 mg Placebo 20d
Placebo 150 mg in healthy participants 20 days
Experimental: 50 mg Active-AD
BMS-984923 50 mg
Experimental: 100 mg Active-AD
BMS-984923 100 mg
Placebo_comparator: Placebo-AD
Placebo matching
Related Therapeutic Areas
Sponsors
Collaborators: Yale University, National Institute on Aging (NIA)
Leads: Allyx Therapeutics

This content was sourced from clinicaltrials.gov