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

NCT06885567 | Not Yet Recruiting Phase 2

• 1 other identifier: BEY-2022-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to investigate the safety and efficacy of BEY2153 in patients with early Alzheimer's Disease. Subjects who meet the inclusion and exclusion criteria will be randomized 1:1:1 to one of three treatment arms for 26 weeks administration. The extension study for additional 26 weeks will be conducted open-label with one treatment arm. Subjects will take BEY2153 orally once a day during the study.

Conditions

Alzheimer Disease; Alzheimer' Disease

Outcome Measures

Primary Outcomes (1)

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

  From Baseline until 4 weeks after the end of treatment

Secondary Outcomes (5)

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

  Baseline and Week 26

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

  Baseline and Week 26

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

  Baseline and Week 26

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

  Baseline and Week 26

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

  Baseline and Week 26

Other Outcomes (3)

• Pharmacodynamics: Change in concentrations of plasma AD-related biomarkers

  Baseline, Week 6 and Week 26

• Brain imaging: Change in brain accumulation of amyloid protein

  Baseline and Week 26

• Brain imaging: Change in brain atrophy

  Baseline and Week 26

Study Arms (3)

BEY2153 dose 1

EXPERIMENTAL

Participants administer 26 weeks

Drug: BEY2153

BEY2153 dose 2

EXPERIMENTAL

Participants administer 26 weeks

Drug: BEY2153

Placebo

PLACEBO COMPARATOR

Participants administer 26 weeks

Drug: Placebo

Interventions

BEY2153 DRUG

Participants administer once daily, PO, 26 weeks

BEY2153 dose 1; BEY2153 dose 2

Placebo DRUG

Participants administer once daily, PO, 26 weeks

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeyondBio Inc.: lead

Study Sites (3)

Severance Hospital

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Yeouido St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease; Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 20, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

KR (3)