A Phase IIa, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 50561 in Patients With Mild or Moderate Alzheimer's Disease

Beijing Joekai Biotechnology LLC12 sites in 1 country68 target enrollmentApril 18, 2023

ConditionsAlzheimer's Disease

Interventions50561 high dose 50561 low dose Placebo

Drugs50561 high dose 50561 low dose Placebo

Overview

Phase: Phase 2
Intervention: 50561 high dose
Conditions: Alzheimer's Disease
Sponsor: Beijing Joekai Biotechnology LLC
Enrollment: 68
Locations: 12
Primary Endpoint: Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center, Phase IIa, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety of two doses of 50561 compared to placebo in participants diagnosed with mild to moderate Alzheimer's disease.

Registry

clinicaltrials.gov

Start Date

April 18, 2023

End Date

September 11, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Joekai Biotechnology LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Agree to participate and sign the informed consent form (ICF) with a legal guardian;
•Male or female subjects aged 50-85 years (inclusive), at the time of informed consent;
•Subjects have received education in primary school and above and are able to complete protocol specified cognitive ability test and other tests;
•Meets the National Institute on Aging -Alzheimer's Association (NIA-AA) core clinical criteria (2011) for probable Alzheimer's disease (AD) dementia;
•Impaired memory for at least 12 months, with a tendency of progressive aggravation;
•Treatment-naive subjects for Alzheimer's disease (AD);
•Mild to moderate Alzheimer's disease (AD):
•(1) Mini-Mental State Examination (MMSE) score of ≥ 11 and \< 26 (2) Clinical Dementia Rating-Global Score (CDR-GS) of 1 or 2;
•8\. Hachinski Ischemic Scale (HIS) score of ≤ 4;
•9\. Hamilton Depression Rating Scale (HAMD) (17-item version) score of ≤ 10;

Exclusion Criteria

•Dementia caused by other reasons: Vascular dementia, central nervous system infection (e.g., AIDS, syphilis), Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, brain trauma dementia, other physical and chemical factors (e.g., drug poisoning, alcohol poisoning, carbon monoxide poisoning), important corporeal diseases (e.g., hepatic encephalopathy, pulmonary encephalopathy), intracranial space-occupying lesions (e.g., subdural hematoma, brain tumors), endocrine system disorders (e.g., thyroid disease, parathyroid disease ) and dementia due to vitamin deficiency or any other known causes;
•Previously had/currently has nervous system disorder (including Neuromyelitis optica, Parkinson's disease, epilepsy);
•Mental disorders confirmed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), including schizophrenia or other mental illness, bipolar disorder, major depression, or delirium;
•Laboratory test abnormalities at screening visit and baseline: Liver function (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) \> 2-fold the upper limit of normal (ULN); Kidney function (creatinine \[Cr\]) \> 1.5-fold the ULN; Creatine kinase (CK) \> 2-fold the ULN; Patients with values that slightly exceed these ranges but are not clinically significant may be included as assessed by the investigator;
•Presence of any one of the following infections at the screening visit:
•(1) Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV-DNA) (exceeding the upper limit of the normal range of the study site); (2) Positive for anti-hepatitis C virus (HCV) antibody (Ab); (3) Positive for human immunodeficiency virus (HIV) Ab; (4) Positive for Treponema pallidum (TP) Ab;
•6\. Presence of other active and poorly managed systemic bacterial, viral, fungal, or parasitic infections (except for fungal nail infection) at the screening visit, or other clinically significant active infections that render the subject unsuitable for study participation as assessed by the investigator;
•7\. Systolic blood pressure (SBP) ≥ 160 mmHg or \< 90 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg or \< 60 mmHg at the screening visit and baseline; Patients with SBP or DBP that slightly exceed this range but is not clinically significant may be included as assessed by the investigator;
•8\. Prolonged corrected QTc interval (Fridericia formula, Appendix 14.1) in the 12-lead electrocardiography (ECG) at screening visit and baseline: Fridericia corrected QT interval (QTcF) \> 450 ms for males and \> 470 ms for females or other clinically significant ECG abnormalities that render the subject unsuitable for study participation (e.g., heart rate \< 50 beats/min, sinus node dysfunction, Mobitz II or third-degree atrioventricular block);
•9\. Patients with unstable or severe cardiovascular, respiratory, digestive, urinary, hematologic, or endocrine disorders within 6 months prior to the screening visit, including pancreatitis, severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, life-threatening ventricular arrhythmia requiring maintenance therapy, pulmonary hypertension, respiratory failure, previous hypoglycemia coma, unstable blood glucose control in diabetic patients, and stroke (including transient ischemic attack), and are unsuitable for study participation as assessed by the investigator;

Arms & Interventions

50561 256mg

50561 at a dose of 256mg n=20 group

Intervention: 50561 high dose

50561 128mg

50561 at a dose of 128mg n=20 group

Intervention: 50561 low dose

placebo

Placebo n=20 group

Intervention: Placebo

Outcomes

Primary Outcomes

Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)

Time Frame: 24 weeks

Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 24 weeks. The total score ranges from 0 to 85, with higher scores representing worse outcome.

Secondary Outcomes

Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)(6 weeks, 12 weeks)
Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)(6 weeks, 12 weeks, 24 weeks)
Mini-Mental State Examination (MMSE)(6 weeks, 12 weeks, 24 weeks)
Alzheimer's Disease Collaborative research group-Activities of Daily Living (ADCS-ADL)(6 weeks, 12 weeks, 24 weeks)
Neuropsychiatric Inventory (NPI)(6 weeks, 12 weeks, 24 weeks)