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CompletedPhase 1Results posted

Evaluating the Safety, Tolerability, Pharmacokinetics and Receptor Occupancy of BMS-984923

An Open-Label, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Receptor Occupancy of BMS-984923

Lead sponsor

Yale University

Asset

BMS-984923

Listed sites

1

Recruiting sites

-

Enrollment

36

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•Count of Treatment Emergent Adverse Events (TEAEs)•Count of Lab Abnormalities•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1U01AG058608-01A1
Org study ID2000028864
NCT IDNCT04805983

Timeline

Milestones

Study first posted2021-03-18actual
Study start2021-03-25actual
Primary completion2022-04-24actual
Study completion2022-04-24actual
Results first posted2023-04-13actual
Last update posted2024-08-27actual

Assets

Drug assets

BMS-984923

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•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

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

2. Male participants who are sexually active with a woman of child-bearing 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.

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

•Glasgow Coma Scale Score of 15 (97)
•Clinical Dementia Rating Score of 0 (93)
•Has a reliable study partner who has frequent contact with the participant (e.g., average of 10 hours per week or more), who can be available for study partner assessments, who can accompany the participant for 48 hours, without absence, after discharge from Visit 2.

Score on the Mini Mental Status Exam > 26 (95)

•Objective memory scores within normal range for age evidenced by a score no more than 1.5 standard deviations 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).

1. >8 for 16 or more years of education

2. >4 for 8-15 years of education

3. >2 for 0-7 years of education

Receptor Occupancy Substudy Eligibility Criteria

•Eligibility for and enrollment in Main Study
•Participant consent to the optional substudy

Exclusion criteria

•Body mass index (BMI) ≥ 35 kg/m2 or body weight < 50 kg.
•Significant cerebrovascular disease: Modified Hachinski score > 4.
•Any significant neurologic disease, such as AD, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
•Major depression, bipolar disorder as described in DSM-IV within the past 1 year.
•Psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol.
•History of schizophrenia (DSM IV criteria).
•History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
•Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results, or the patient's ability to participate in the study.
•Clinically significant abnormalities in B12 or Thyroid Function Tests that might interfere with the study.

Use of psychoactive medications (typical neuroleptics, narcotic analgesics, antiparkinsonian medications, systemic corticosteroids, or medications with significant central anticholinergic activity) within 2 weeks or 5 half-lives (whichever is greater) prior to study drug administration and for the duration of the trial.

•Use of medications with significant CYP1A2, 2D6, or 3A4 inhibitor or inducer activity (See appendix for a list of these medications) within 2 weeks or 5 half-lives (whichever is greater) prior to study drug administration and for the duration of the trial.
•Use of anticoagulants within 30 days or 5 half-lives (whichever is greater) prior to study drug administration and for the duration of the trial.
•Use of investigational amyloid lowering therapies within 2 months prior to study drug administration and for the duration of the trial.
•Use of another investigational agent within 30 days or 5 half-lives (whichever is greater) prior to screening and for the duration of the trial.
•Neutropenia defined as absolute neutrophils count of < 1,500/microliter.
•Thrombocytopenia defined as platelet count < 100,000/microliter.
•Clinically significant abnormalities in screening laboratories, including Aspartate aminotransferase (AST) >1.5 times upper limit of normal (ULN); Alanine aminotransferase (ALT) >1.5 times ULN; Total bilirubin >1.5 times ULN; Serum creatinine >2.0 times ULN.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
10
Global cognition
2
Other (unclassified)
2

Global cognition

2 endpoints
Primary/protocol endpoint

Count of Clinically Significant Changes in Safety Assessments

Time frame:Up to 7 days after last dose

Neuropsychiatric Inventory (NPI)

event count, event

Primary/registry result

Count of Clinically Significant Changes in Safety Assessments

Time frame:Up to 7 days after last dose

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
10 mg BMS-984923n=6 Participants0-
40 mg BMS-984923n=6 Participants0-
70 mg BMS-984923n=6 Participants0-
100 mg BMS-984923n=6 Participants0-
150 mg BMS-984923n=6 Participants0-
200 mg BMS-984923n=6 Participants0-

Safety / tolerability / PK

10 endpoints
Primary/protocol endpoint

Count of Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to 7 days after last dose

event count, event

Primary/protocol endpoint

Maximum Plasma Concentration (Cmax)

Time frame:Up to 7 days after last dose

concentration, descriptive

Primary/protocol endpoint

Time of Cmax (Tmax)

Time frame:Up to 7 days after last dose

concentration, descriptive

Primary/protocol endpoint

Area Under the Curve From 0 to 24h (AUC 24h)

Time frame:Up to 7 days after last dose

concentration, descriptive

Primary/registry result

Count of Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to 7 days after last dose

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
10 mg BMS-984923n=6 Participants2-
40 mg BMS-984923n=6 Participants2-
70 mg BMS-984923n=6 Participants2-
100 mg BMS-984923n=6 Participants1-
150 mg BMS-984923n=6 Participants3-
200 mg BMS-984923n=6 Participants3-
Primary/registry result

Maximum Plasma Concentration (Cmax)

Time frame:Up to 7 days after last dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
10 mg BMS-984923n=6 Participants21.867.85
40 mg BMS-984923n=6 Participants189.1582.18
70 mg BMS-984923n=6 Participants293.22150.56
100 mg BMS-984923n=6 Participants125.8562.72
150 mg BMS-984923n=6 Participants480.83235.19
200 mg BMS-984923n=6 Participants455.65167.88
Primary/registry result

Time of Cmax (Tmax)

Time frame:Up to 7 days after last dose

concentration, descriptive

Posted result

GroupValue (mean), hoursStandard deviation
10 mg BMS-984923n=6 Participants1.50.548
40 mg BMS-984923n=6 Participants1.670.516
70 mg BMS-984923n=6 Participants2.171.472
100 mg BMS-984923n=6 Participants2.170.983
150 mg BMS-984923n=6 Participants1.830.408
200 mg BMS-984923n=6 Participants3.331.03
Primary/registry result

Area Under the Curve From 0 to 24h (AUC 24h)

Time frame:Up to 7 days after last dose

concentration, descriptive

Posted result

GroupValue (mean), ng∙h/mLStandard deviation
10 mg BMS-984923n=6 Participants105.2948.48
40 mg BMS-984923n=6 Participants993.74345.23
70 mg BMS-984923n=6 Participants1547.62765.72
100 mg BMS-984923n=6 Participants967.563130.23
150 mg BMS-984923n=6 Participants3130.231655.51
200 mg BMS-984923n=6 Participants3752.11259.84
Secondary/protocol endpoint

Receptor Occupancy

Time frame:Up to 24 hours after last dose

threshold achievement, event

Secondary/registry result

Receptor Occupancy

Time frame:Up to 24 hours after last dose

threshold achievement, event

Posted result

GroupValue (mean), ng/mLStandard error
All ParticipantsIC50n=8 Participants33.94
IC80n=8 Participants136.716

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Count of Lab Abnormalities

Time frame:Up to 7 days after last dose

event count, event

Primary/registry result/low confidence

Count of Lab Abnormalities

Time frame:Up to 7 days after last dose

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
10 mg BMS-984923n=6 Participants0-
40 mg BMS-984923n=6 Participants0-
70 mg BMS-984923n=6 Participants0-
100 mg BMS-984923n=6 Participants0-
150 mg BMS-984923n=6 Participants0-
200 mg BMS-984923n=6 Participants0-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.