Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease

Last updated: December 29, 2018
Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Memory Loss

Alzheimer's Disease

Dementia

Treatment

N/A

Clinical Study ID

NCT03790982
AD-35-II-01
  • Ages 50-75
  • All Genders

Study 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 run in China involving 21 sites. It will enroll approximately 480 patients to ensure 240 randomized with mild to moderate Alzheimer's Disease. The treatment period is 52 weeks and total study duration per patient is approximately 57 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 memoryscore ≥ 0.5).

  • Subjects must have a brain magnetic resonance imaging (MRI) scan that is consistentwith a clinical diagnosis of probable AD. Brain atrophy and medial temporal lobeatrophy visual assessment scale MTA grading >2 points. Mild white matter degenerationmay occur, but Fazekas less than or equal to 2 points and supratentorial lacunarinfarction 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

Exclusion Criteria:

  • Visual, hearing and verbal communication of subjects cannot meet the needs ofcognitive function evaluation.

  • Inability to tolerate MRI procedures or contraindication to MRI, (such as implanted inthe body, MRI incompatible pacemakers, implantable cardioverter defibrillators,cochlear implants, aneurysm clips, implanted injection pump, implanted nervestimulator, metallic splinters in the eye, other magnetic, electrical and other metalimplants) [note], or any other situation, in the judgment of the Investigator, is notsuitable for magnetic resonance imaging (MRI).

  • The investigators believe that other severe or unstable conditions may interfere withthe 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) andother reasons.

Study Design

Total Participants: 240
Study Start date:
December 01, 2018
Estimated Completion Date:
July 30, 2021

Study 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 assigned 1:1:1 to receive placebo, or different doses of AD-35 tablet (30 or 60 mg). After the first 26 weeks, subjects on active study drug will remain on the current doses, and subjects assigned to placebo will be randomized to receive 30 mg and 60 mg AD-35 tablet in a 1:1 ratio, respectively, for the second 26 weeks. This study will evaluate the safety, preliminary efficacy and pharmacokinetics of AD-35 tablets in patients with mild to moderate Alzheimer's Disease.

Connect with a study center

  • The Department of Neurosurgery

    Beijing, Beijing 100010
    China

    Site Not Available

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