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Alzheimer DiseasePhase 2NCT06885567

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

A Phase 2 study testing BEY2153 in people with Alzheimer Disease and Alzheimer' Disease, run by BeyondBio Inc. at 3 sites in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer Disease, Alzheimer' Disease
What is being tested?
BEY2153
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
3 sitesSouth Korea
Study dates
Jul 2025to Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Patients who completed the 26-week visit in the Main Study
  • Patients who provided written consent to participate in the Extension Study

Who cannot join

  • 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
Show all 30Show fewer
  • 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]
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea3 sites

  • Severance Hospital

    Seoul

    BeyondBio Inc., +82-42-716-0020, clinicaltrials@beyondbio.co.kr

  • SMG-SNU Boramae Medical Center

    Seoul

    Beyondbio Inc., +82-42-716-0020, clinicaltrials@beyondbio.co.kr

  • Yeouido St. Mary's Hospital

    Seoul

    BeyondBio Inc., +82-42-716-0020, clinicaltrials@beyondbio.co.kr

Other trials in South Korea

About this study

Official title: 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

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.

Being tested
BEY2153, Placebo
Medical subject headings
Alzheimer Disease, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEY2153Drug

    Participants administer once daily, PO, 26 weeks

  • PlaceboDrug

    Participants administer once daily, PO, 26 weeks

Study groups in NCT06885567
Study groupRoleWhat they receive
BEY2153 dose 1ExperimentalParticipants administer 26 weeks
Receives: Drug: BEY2153
BEY2153 dose 2ExperimentalParticipants administer 26 weeks
Receives: Drug: BEY2153
PlaceboPlacebo comparatorParticipants administer 26 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From Baseline until 4 weeks after the end of treatment

Secondary outcomes (5)

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

    Measured: Baseline and Week 26

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

    Measured: Baseline and Week 26

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

    Measured: Baseline and Week 26

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

    Measured: Baseline and Week 26

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

    Measured: Baseline and Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885567
Sponsor's protocol ID
BEY-2022-01
Status last verified
Mar 2025
First submitted
10 Mar 2025
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BEY2153 in people with Alzheimer Disease and Alzheimer&#39; Disease, run by BeyondBio Inc. at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06885567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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