Status:
UNKNOWN
Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Zhejiang Hisun Pharmaceutical Co. Ltd.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-75 years
Phase:
PHASE2
Brief Summary
Brief summary: This is a phase II study to investigate the safety, preliminary efficacy and pharmacokinetics of AD-35 tablet in patients with mild to moderate Alzheimer's Disease. This study is to be ...
Detailed Description
In this multicenter, randomized, double blind, parallel-group, placebo controlled phase II study, 240 patients with mild to moderate Alzheimer's Disease are planned to be enrolled and randomly assigne...
Eligibility Criteria
Inclusion
- Men and women, 50-75 years of age.
- Formal education of five or more years.
- Diagnosed of probable AD in accordance with the NINCDS/ADRDA criteria (2011).
- Mild or moderate AD subjects: MMSE Score of 15-26 and CDR Score ≥ 0.5 (CDR memory score ≥ 0.5).
- Subjects must have a brain magnetic resonance imaging (MRI) scan that is consistent with a clinical diagnosis of probable AD. Brain atrophy and medial temporal lobe atrophy visual assessment scale MTA grading \>2 points. Mild white matter degeneration may occur, but Fazekas less than or equal to 2 points and supratentorial lacunar infarction lesions less than or equal to 3 points.
- The total score of modified Hachinski ischemia scale (MHIS) ≤ 4.
- Hamilton depression scale (HAMD) has a total score ≤ 17.
Exclusion
- Visual, hearing and verbal communication of subjects cannot meet the needs of cognitive function evaluation.
- Inability to tolerate MRI procedures or contraindication to MRI, (such as implanted in the body, MRI incompatible pacemakers, implantable cardioverter defibrillators, cochlear implants, aneurysm clips, implanted injection pump, implanted nerve stimulator, metallic splinters in the eye, other magnetic, electrical and other metal implants) \[note\], or any other situation, in the judgment of the Investigator, is not suitable for magnetic resonance imaging (MRI).
- The investigators believe that other severe or unstable conditions may interfere with the cognitive evaluation in clinical trials.
- Dementia caused by other reasons: vascular dementia, central nervous system infection, endocrine system diseases (such as thyroid disease, parathyroid gland disease) and other reasons.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2021
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03790982
Start Date
December 1 2018
End Date
July 30 2021
Last Update
January 2 2019
Active Locations (1)
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1
The Department of Neurosurgery
Beijing, Beijing Municipality, China, 100010