Alzheimer's Disease, AD
Conditions
Interventions
Intervention group (50 mg):A total of 24 subjects will be enrolled and randomized in a 3:1 ratio to receive either BrAD-R13 or placebo. 18 subjects are assigned to BrAD-R13 group (50 mg, twice daily)
Intervention group (100 mg):8 subjects will be enrolled and randomized in a 3:1 ratio to receive either BrAD-R13 or placebo. 6 subjects are assigned to BrAD-R13 group (100 mg, twice daily) and 2 subje
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for this study: 1. Age and Sex: Aged between 50 and 85 years (inclusive), regardless of sex. 2. Disease Diagnosis: Meet the criteria for mild or moderate functional impairment due to Alzheimer's Disease (AD) as defined by Stages 4-5 of the Alzheimer's Association (AA) 2024 criteria. 3. Cognitive Assessment Scores:Mini-Mental State Examination (MMSE) score: between 10 and 24 points (inclusive) for non-illiterate individuals. Clinical Dementia Rating-Sum of Boxes (CDR-SB) score: between 0.5 and 2 points (inclusive). 4. Caregiver Support: Must have a stable and reliable caregiver, or frequent contact with a caregiver (at least 4 days per week, 2 hours per day). The caregiver must accompany the subject to study visits, interact sufficiently with the subject, and assist the investigator with scale assessments. 5. Informed Consent: The subject and their legal guardian voluntarily agree to participate in the trial and provide written informed consent.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they meet any of the following criteria: 1.Non-AD Dementias: Cognitive impairment or dementia due to any etiology other than AD, including but not limited to: Other neurodegenerative diseases (e.g., Dementia with Lewy Bodies, Frontotemporal Lobar Degeneration, Huntington's Disease, Parkinson's Disease). Non-degenerative neurological disorders (e.g., Vascular Cognitive Impairment or Dementia, HIV-associated dementia, Neurosyphilis, Encephalitis, Hypoxic-ischemic Brain Injury, Traumatic Brain Injury, Epileptic Dementia). 2.Systemic Causes of Cognitive Impairment: Cognitive impairment or dementia due to non-neurological conditions, including but not limited to: Endocrine disorders (e.g., Hypothyroidism); Hepatic Encephalopathy, Pulmonary Encephalopathy, Dialysis Encephalopathy; Toxic encephalopathies (including alcohol intoxication, drug intoxication, carbon monoxide poisoning); Vitamin deficiencies (e.g., B12 deficiency, B1 deficiency, folate deficiency); 3.Significant Focal Brain Lesions: Presence of significant focal lesions suggestive of non-AD pathology on neuroimaging (e.g., large cerebral infarction, multiple lacunar infarcts, moderate to severe white matter lesions, space-occupying lesions, intracranial hemorrhage, hydrocephalus, infarcts in key areas such as thalamus, hippocampus, entorhinal cortex, or perirhinal cortex). 4.Significant Psychiatric Disorders: Any psychiatric disorder meeting DSM-5 diagnostic criteria that, in the investigator's judgment, may affect cognitive assessment or study compliance (e.g., mania, bipolar disorder, schizophrenia or schizoaffective disorder, major depressive disorder with MADRS score >= 30, anxiety disorders, obsessive-compulsive and related disorders, trauma- and stressor-related disorders, dissociative disorders, anorexia nervosa or bulimia nervosa). 5.Sensory Impairment: Significant auditory or visual impairment preventing completion of neuropsychological tests. 6.Inability to Tolerate Standard AD Medications: Inability to regularly take standard anti-AD medications. 7.Stem Cell Therapy: Receipt of stem cell therapy within 6 months prior to randomization. 8.Prohibited Medications: Current use or anticipated need during the study period for any medication prohibited by the study protocol. 9. Uncontrolled Medical Conditions: History within 6 months prior to screening of severe or poorly controlled neurological, cardiovascular, or other diseases (e.g., stroke, acute myocardial infarction, unstable angina, chronic heart failure NYHA Class III or IV). 10.Malignancy: Active malignancy or history of malignancy within 5 years prior to screening (exceptions: successfully treated non-metastatic basal cell or squamous cell skin carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ). 11.Active Infection: Poorly controlled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infections) or any other clinically significant active infection at screening, as judged by the investigator. 12.Active Viral Infections / Tuberculosis: Laboratory evidence of active HBV, HCV, HIV, or syphilis infection (exceptions: prior hepatitis infection with curative treatment and current non-active viral load; prior syphilis with adequate treatment and no current evidence of active transmission). 13.Active Tuberculosis (TB) infection, currently on anti-TB treatment or within 1 year prior to the first dose. 14.Gastrointestinal Disorders: Dys
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Laboratory tests ;Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs);Pharmacokinetic parameters;Biomark;Clinical Cognitive Function Rating Scale; | — |
Countries
China
Contacts
Public ContactJun Shi
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed