Not yet recruitingPhase 2

A Phase 2 Study to Evaluate the Safety and Efficacy of BEY2153 in Patients with Early Alzheimer's Disease

A Multicenter, Randomized, Double-blind, Parallel Design, Placebo-controlled, Phase 2 Clinical Trial and Open-Label Extension Study to Evaluate the Safety and Efficacy for BEY2153 in Patients with Early Alzheimer's Disease

Lead sponsor

BeyondBio Inc.

Asset

BEY2153

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)•MMSE ≥20

Primary endpoint

•Safety

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

Org study IDBEY-2022-01

NCT IDNCT06885567

Timeline

Milestones

Study first posted2025-03-20actual

Last update posted2025-03-20actual

Study start2025-07estimated (month precision)

Primary completion2028-07estimated (month precision)

Study completion2028-08estimated (month precision)

Assets

Drug assets

BEY2153

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male and female adults at the age of ≥ 55 to ≤ 85 at the time of informed consent

•Patients diagnosed according to the NIA-AA 2024 Criteria for Diagnosis with Mild Cognitive Impairment (MCI) or diagnosed with mild Alzheimer's disease

•CDR-GS 0.5-1.0 at Screening

•MMSE ≥ 20 at Screening

•Amyloid-positive at amyloid PET scan

•Patients who are capable of understanding information provided and can voluntarily sign written informed consent form

Exclusion criteria

•Subjects diagnosed with cognitive impairment due to causes other than substrate causes such as brain lesions, psychiatric disorders, or Alzheimer's disease (e.g., stroke, Parkinson's disease, Lewy body disease, vascular dementia)

•Subjects with any of the following cardiovascular diseases at Screening

* Cerebrovascular disease within the past 6 months (cerebral infarction, cerebral hemorrhage, transient ischemic attack, etc.)

-Myocardial infarction or unstable angina pectoris within the past 6 months

-New York Heart Association (NYHA) Class II congestive heart failure

-QTcF ≥450 msec or clinically significant electrocardiogram (ECG) abnormalities

•Patients with malignant tumors

•Patients with medical conditions that can affect cognitive decline such as hypothyroidism, vitamin B12 or folate deficiency, niacin deficiency, etc.

•Patients with a history of alcohol related disorders within the past 6 months

•Patients with a positive HIV antibody test result at Screening

•Patients with a positive HBs antigen or HCV antibody test at Screening

•Patients with active bacterial infections who have received antibiotics within 7 days prior to Screening.

•Patients with a history of hypersensitivities to any of the components of investigational product

•Patients who have been hospitalized or treated for suicidal behavior within 5 years prior to Screening or whose C-SSRS results at Screening indicate serious suicidal ideation or behavior

•Patients who have received treatment for Alzheimer's disease (e.g., Lecanemab) within 6 months prior to Screening

•Patients expected to require the administration of a long-acting benzodiazepine (BDZ) for the treatment of sleep disorders at Screening

•Any of the following laboratory test values at Screening:

-Serum Creatinine >1.5×ULN or eGFR (MDRD) <40 mL/min/1.73 m2

-Any of the following: AST, ALT >3×ULN, or Total bilirubin >2xULN

•Women who test positive for pregnancy at Screening, or women and men of childbearing potential who are planning to become pregnant, or who do not agree to use adequate contraception* during the study and for 4 weeks after the end of study drug administration

*Adequate contraception: complete abstinence, hormonal contraceptives with no known drug interactions [Levonorgestrel intrauterine system (IUS) (Mirena), Medroxyprogesterone], surgical sterilization (including vasectomy, bilateral salpingectomy and ligation). However, intermittent abstinence (e.g., using ovulation timing, symptothermal method, or post-ovulation) or external ejaculation are not considered adequate contraception.

•Pregnant or lactating women or women who are tested positive for pregnancy at Screening

•Patients treated with other IP within 4 weeks prior to screening

•Patients who are considered ineligible for study participation for other reasons based on the judgment of the investigator

[Extension Study]

Inclusion Criteria:

•Patients who completed the 26-week visit in the Main Study

•Patients who provided written consent to participate in the Extension Study

Exclusion Criteria:

•Subjects who have dropped out of the Main Study

•Patients who, in the investigator's judgement, are not suitable for participation in Extension Study

•Any of the following laboratory test values at Baseline:

-Serum Creatinine >1.5×ULN or eGFR (MDRD) <40 mL/min/1.73 m2

-Any of the following: AST, ALT >3×ULN, or Total bilirubin >2xULN

Endpoints (9)

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

Global cognition

Amyloid biomarkers

Other (unclassified)

Caregiver / quality of life

Safety / tolerability / PK

Global cognition

3 endpoints

Secondary/protocol endpoint

Change from Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) after 26-week treatment

Time frame:Baseline and Week 26

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Mini Mental State Exam (MMSE) after 26-week treatment

Time frame:Baseline and Week 26

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13) after 26-week treatment

Time frame:Baseline and Week 26

ADAS-Cog

change from baseline, improvement

Amyloid biomarkers

2 endpoints

Other/protocol endpoint

Pharmacodynamics: Change in concentrations of plasma AD-related biomarkers

Time frame:Baseline, Week 6 and Week 26

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Other/protocol endpoint

Brain imaging: Change in brain accumulation of amyloid protein

Time frame:Baseline and Week 26

Amyloid PET Centiloid

change from baseline, improvement

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus) after 26-week treatment

Time frame:Baseline and Week 26

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety: Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame:From Baseline until 4 weeks after the end of treatment

event count, event

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change from Baseline in Alzheimer's Disease Composite Score (ADCOMS) after 26-week treatment

Time frame:Baseline and Week 26

change from baseline, improvement

Other/protocol endpoint/low confidence

Brain imaging: Change in brain atrophy

Time frame:Baseline and Week 26

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.