Actively Recruiting
A Study of Oral EX039 in Subjects with Mild Alzheimer's Disease
Led by Excelsior · Updated on 2025-02-26
120
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
E
Excelsior
Lead Sponsor
F
Formosa Biomedical Technology Corp.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2, randomized, double-blind, placebo-controlled study of oral EX039 as add-on to Acetylcholine Esterase Inhibitors in subjects with mild Alzheimer's disease.
CONDITIONS
Official Title
A Study of Oral EX039 in Subjects with Mild Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50-80 years.
- Clinical diagnosis of probable mild Alzheimer's disease dementia based on NINCDS/ADRDA criteria (2011).
- Mini Mental State Exam score between 10 and 26 within the last 3 months.
- Clinical Dementia Rating score of 1 within the last 3 months.
- Physically healthy with laboratory tests within normal range or meeting specified criteria.
- Complaints of subjective memory impairment and cognitive disturbances including memory loss and at least one other cognitive disturbance.
- Cognitive deficits that impair social or occupational function.
- Disease progression with gradual and continued decline from previous functioning.
- Female subjects must be non-childbearing or use birth control if of childbearing potential; males must use birth control if sexually active.
- Sufficient education (at least elementary level) to communicate effectively and complete study assessments.
You will not qualify if you...
- Other causes of dementia.
- Substantial cerebrovascular disease related to stroke or intracranial hemorrhage.
- Cancer history or treatment within last 5 years (except basal cell carcinoma).
- Unstable or uncontrolled cardiovascular illnesses, significant ischemic heart disease, or other serious heart conditions.
- Significant gastrointestinal disorders such as recent bleeding or active ulcers.
- Uncontrolled endocrine diseases like diabetes or hyperthyroidism.
- Unstable or uncontrolled major depression.
- Neurological diseases other than Alzheimer's dementia.
- Significant pulmonary disease causing hypoxia.
- Major physical illnesses such as brain tumors or craniocerebral trauma.
- Psychiatric disorders including schizophrenia or mental retardation.
- Suicidal actions in past 2 years.
- Hachinski Ischemic Score greater than 4.
- Significant history of drug or alcohol dependence or abuse.
- Clinically significant hearing loss not compensated by hearing aids.
- Any condition deemed ineligible by investigators, including inability to swallow capsules whole.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
C
Cliff Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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