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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Aged 50-80 years.

• Clinical diagnosis of probable mild Alzheimer disease dementia based on National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA criteria, 2011)

• Last time (which must be within 3 months ) of Mini Mental State Exam (MMSE) between 10-26.

• Last time (which must be within 3 months) of Clinical Dementia Rating (CDR) score of 1.

• Physically healthy and all laboratory assessments (including hematology, chemistry, urinalysis and electrocardiograph) are within normal range or meet the following criteria:

‣ AST, ALT level ≦ upper limit of normal

⁃ Creatine Kinase (CK) concentration more than 3 times upper limit of normal

⁃ Serum creatinine level ≦ upper limit of normal

⁃ HbA1c more than 8.0

• Complaints of subjective memory impairment and cognitive disturbances by patients themselves or caregivers, including memory loss and at least one of the following cognitive disturbances: language, perceptual skills, attention, constructive abilities, orientation, problem solving, functional abilities.

• Cognitive deficits caused impairment in social or occupational function.

• Disease progression with gradual and continued decline from a previous level of functioning.

• Female subjects must be of non-childbearing potential (greater than 1 year without menstrual period in the absence of hormone replacement therapy) or surgically sterile. If pre-menopausal or menopausal for 1 year or less, must have a negative pregnancy test and must not be lactating at screening visit. Female subjects of childbearing potential and who are sexually active are required to practice adequate methods of birth control. Male subjects who are sexually active will also be required to use an adequate form of birth control.

• Has sufficient education equivalent to elementary education to communicate effectively and were capable of completing the assessments of the study.

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Cliff Lin
cliff.lin@excelsiorgroup.com.tw
+886-972821234
Time Frame
Start Date: 2022-08-08
Estimated Completion Date: 2027-02
Participants
Target number of participants: 120
Treatments
Experimental: 1000 mg
The recruited patient randomly assigned to this arm will take 1000 mg EX039 per day
Experimental: 750 mg
The recruited patient randomly assigned to this arm will take 750 mg EX039 per day
Placebo_comparator: placebo
The recruited patient randomly assigned to this arm will take placebo per day
Related Therapeutic Areas
Sponsors
Leads: Excelsior
Collaborators: Formosa Biomedical Technology Corp.

This content was sourced from clinicaltrials.gov

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