AzTrials
AzTrials

Alzheimer's DiseasePhase 2NCT05811442

Study of 50561 in Patients With Mild or Moderate Alzheimer's Disease

A Phase 2 study testing 50561 high dose and 50561 low dose in people with Alzheimer's Disease, run by Beijing Joekai Biotechnology LLC at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
50561 high dose and 50561 low dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
12 sitesChina
Study dates
18 Apr 2023to 11 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • 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);
Show all 17Show fewer
  • Mild to moderate Alzheimer's disease (AD):
  • 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;
  • 10. Cranial magnetic resonance imaging (MRI) plain scan and oblique coronal hippocampal scan:
  • Age-adjusted medial temporal lobe atrophy scale [MTA scale] score: Score 2 or more for < 75 years, score 3 or more for ≥ 75 years;
  • Infarction lesions larger than 2 cm in diameter ≤ 2
  • Without infarction lesion in vital sites, such as the thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, angular gyrus, cortex, and other subcortical gray matter nuclei;
  • Fazekas Scale ≤ 2.
  • 11. If female with childbearing potential, tests negative for pregnancy at screening and baseline visits. Male and female patients with childbearing potentials agree to use contraceptives with an annual failure rate of < 1% throughout the trial and for 90 d after the last dose;
  • 12. Subject shall have a stable and reliable caregiver who provides care for at least 2 h per day for 4 d per week. The caregiver must accompany the subject in all visits and have sufficient interaction and communication with the subject in order to assist the investigator in completing the relevant assessments.

Who cannot join

  • 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:
  • 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;
Show all 22Show fewer
  • 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;
  • 10. Presence of gastrointestinal disorder that, as assessed by the investigator, can impact drug absorption or metabolism within 6 months prior to the screening visit;
  • 11. Underwent major surgery within 6 months prior to the screening visit that renders the patient unsuitable for enrollment or planning to undergo major surgery during the study;
  • 12. Suffered from a malignant tumor within 3 years prior to the screening visit (excluding resected basal cell carcinoma or cutaneous squamous cell carcinoma , and/or resected carcinoma in situ);
  • 13. Received other traditional Chinese or Western nootropic medications/treatments within 4 weeks prior to baseline;
  • 14. Use of strong CYP3A4 inhibitor or strong CYP3A4 inducer within 4 weeks or 5 half-lives (whichever is longer) prior to baseline;
  • 15. Received other investigational drugs within 4 weeks prior to baseline;
  • 16. Received vaccines within 4 weeks prior to baseline;
  • 17. Alcohol abuse or drug abuse within 1 year prior to the screening visit;
  • 18. History of severe allergy, non-allergic drug reaction or multiple drug allergy, or known history of allergy to 50561 tablet and its excipients;
  • 19. Lacks adequate premorbid literacy, adequate vision, or adequate hearing to complete the required psychometric tests;
  • 20. Breastfeeding women;
  • 21. Other conditions that render the subject unsuitable for study participation as assessed by the investigator.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing Anding Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong

  • Heilongjiang Provincial Hospital of Traditional Chinese Medicine

    Haerbin, Heilongjiang

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • The First affiliated hospital of SOOCHOW university

    Suzhou, Jiangsu

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality

  • Wuhan Union Hospital of China

    Wuhan, Hubei

Other trials in China

About this study

Official title: 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

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.

Being tested
50561 high dose, 50561 low dose, Placebo
Keywords
Alzheimer's disease, 50561, Rac1
Medical subject headings
Alzheimer Disease

What participants receive

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

  • 50561 high doseDrug

    study drug

  • 50561 low doseDrug

    study drug

  • PlaceboDrug

    Non-active study drug

Study groups in NCT05811442
Study groupRoleWhat they receive
50561 256mgExperimental50561 at a dose of 256mg n=20 group
Receives: Drug: 50561 high dose
50561 128mgExperimental50561 at a dose of 128mg n=20 group
Receives: Drug: 50561 low dose
placeboPlacebo comparatorPlacebo n=20 group
Receives: Drug: Placebo

What is being measured

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

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

    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.

    Measured: 24 weeks

Secondary outcomes (6)

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

    Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 6 weeks and 12 weeks. The total score ranges from 0 to 85, with higher scores representing worse outcome.

    Measured: 6 weeks, 12 weeks

  2. Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

    Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale at 6 weeks, 12 weeks and 24 weeks. The total score ranges from 0 to 18, with higher scores representing worse outcome.

    Measured: 6 weeks, 12 weeks, 24 weeks

  3. Mini-Mental State Examination (MMSE)

    Change from baseline in the Mini-Mental State Examination (MMSE) at 6 weeks, 12 weeks and 24 weeks. The total score ranges from 0 to 30, with higher scores representing better outcome.

    Measured: 6 weeks, 12 weeks, 24 weeks

  4. Alzheimer's Disease Collaborative research group-Activities of Daily Living (ADCS-ADL)

    Change from baseline in the Alzheimer's Disease Collaborative research group-Activities of Daily Living (ADCS-ADL) at 6 weeks, 12 weeks and 24 weeks. The total score ranges from 0 to 78, with higher scores representing better outcome.

    Measured: 6 weeks, 12 weeks, 24 weeks

  5. Neuropsychiatric Inventory (NPI)

    Change from baseline in the 12-item behavioral domain scores on the Neuropsychiatric Inventory (NPI) scale at 6 weeks, 12 weeks and 24 weeks. The total score ranges from 0 to 144, with higher scores representing worse outcome.

    Measured: 6 weeks, 12 weeks, 24 weeks

  6. Neuropsychiatric Inventory (NPI)

    Change from baseline in the caregiver stress scores on the Neuropsychiatric Inventory (NPI) scale at 6 weeks, 12 weeks and 24 weeks. The total score ranges from 0 to 60, with higher scores representing worse outcome.

    Measured: 6 weeks, 12 weeks, 24 weeks

Timeline

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

  1. First posted13 Apr 2023
  2. Study start18 Apr 2023
  3. Primary completion22 Aug 2025
  4. Study completion11 Sep 2025

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05811442
Sponsor's protocol ID
50561-II-01
Status last verified
Sep 2025
First submitted
28 Mar 2023
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 50561 high dose and 50561 low dose in people with Alzheimer's Disease, run by Beijing Joekai Biotechnology LLC at 12 sites in China.

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 17 inclusion and 22 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: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) (time frame: 24 weeks). 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 NCT05811442.

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 18 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in