A Randomized, Double Blind, Placebo Controlled, Parallel-Group 52-week Multicenter Phase II Study to Investigate the Safety, Efficacy and Pharmacokinetics of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease

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

Sponsors

Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.

Source Zhejiang Hisun Pharmaceutical Co. Ltd.
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 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.

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 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.

Overall Status Active, not recruiting
Start Date December 1, 2018
Completion Date July 30, 2021
Primary Completion Date December 30, 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11 scores Week 26
Changes in Alzheimer's Disease Cooperative Study-clinical global impression of change (ADCS-CGIC ) scores Week 26
Secondary Outcome
Measure Time Frame
Changes in ADAS-Cog11 scores Week 6, week 13, week 39, week52
Enrollment 240
Condition
Intervention

Intervention type: Drug

Intervention name: Placebo of AD-35 60mg /AD-35 30mg

Description: Placebo 60mg, oral, 1st 26 weeks; AD-35 30mg +Placebo of AD-35 30mg oral 2nd 26 weeks.

Arm group label: Placebo of AD-35 60mg /AD-35 30mg

Other name: Placebo of AD-35

Intervention type: Drug

Intervention name: Placebo of AD-35 60mg /AD-35 60mg

Description: Placebo 60mg, oral, 1st 26 weeks; AD-35 60mg oral, 2nd 26 weeks.

Arm group label: Placebo of AD-35 60mg /AD-35 60mg

Other name: Placebo 60mg

Intervention type: Drug

Intervention name: AD-35 30 mg + Placebo of AD-35 30 mg

Description: AD-35 30 mg + Placebo of AD-35 30 mg AD-35 30 mg + Placebo of AD-35 30 mg, Oral, 52 weeks.

Arm group label: AD-35 30 mg+Placebo of AD-35 30 mg

Other name: AD-35

Intervention type: Drug

Intervention name: AD-35 60 mg

Description: AD-35 60 mg AD-35 30 mg x two tablets, oral, 52 weeks.

Arm group label: AD-35 60 mg

Other name: AD-35

Eligibility

Criteria:

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 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 Criteria:

- 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.

Gender: All

Minimum age: 50 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jianping Jia, PhD Principal Investigator Xuanwu hospital, capital medical university, Beijing, China
Location
facility The Department of Neurosurgery
Location Countries

China

Verification Date

December 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Placebo of AD-35 60mg /AD-35 30mg

Arm group type: Placebo Comparator

Description: Placebo of AD-35 60 mg Placebo of AD-35 30mg x two tablets, once daily in the first 26 weeks (oral), then AD-35 30mg +Placebo of AD-35 30mg, once daily in the second 26 weeks (oral)

Arm group label: Placebo of AD-35 60mg /AD-35 60mg

Arm group type: Placebo Comparator

Description: Placebo of AD-35 60 mg Placebo of AD-35 30mg x two tablets, once daily in the first 26 weeks (oral), then AD-35 30mg x two tablets, once daily in the second 26 weeks (oral)

Arm group label: AD-35 30 mg+Placebo of AD-35 30 mg

Arm group type: Experimental

Description: AD-35 30 mg + Placebo of AD-35 30 mg AD-35 30 mg + Placebo of AD-35 30 mg, once daily for 52 weeks (oral)

Arm group label: AD-35 60 mg

Arm group type: Experimental

Description: AD-35 60 mg AD-35 30 mg× two tablets, once daily for 52 weeks (oral)

Acronym WAY
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Parallel Assignment, Multiple Groups, Multiple Centers

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Masking description: Double (Participant, Investigator)

Source: ClinicalTrials.gov