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

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Placebo of AD-35 60mg /AD-35 30mg

Placebo of AD-35 60mg /AD-35 60mg

AD-35 30 mg + Placebo of AD-35 30 mg

AD-35 60 mg

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring AD-35 tablet, Alzheimer's Disease, Phase II study

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Department of Neurosurgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo of AD-35 60mg /AD-35 30mg

Placebo of AD-35 60mg /AD-35 60mg

AD-35 30 mg+Placebo of AD-35 30 mg

AD-35 60 mg

Arm 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)

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)

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)

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

Outcomes

Primary Outcome Measures

Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11 scores

Changes in the total of ADAS-Cog11 scores of treatment compared with baseline. The score ranged from 0 to 75, and the higher the score, the greater the cognitive impairment

Changes in Alzheimer's Disease Cooperative Study-clinical global impression of change (ADCS-CGIC ) scores

Changes in ADCS-CGIC scores of treatment compared with baseline. The overall condition of the disease change is assessed (improved or deteriorated) by the doctor and the patient, and the 8-point scoring method (0-7 points) was adopted.

Secondary Outcome Measures

Changes in ADAS-Cog11 scores

Changes in ADCS-CGIC scores of treatment compared with baseline

Full Information

NCT ID

NCT03790982

First Posted

December 18, 2018

Last Updated

December 29, 2018

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03790982

Brief Title

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

Acronym

WAY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

AD-35 tablet, Alzheimer's Disease, Phase II study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment, Multiple Groups, Multiple Centers

Masking

ParticipantInvestigator

Masking Description

Double (Participant, Investigator)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo of AD-35 60mg /AD-35 30mg

Arm Type

Placebo Comparator

Arm 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 Title

Placebo of AD-35 60mg /AD-35 60mg

Arm Type

Placebo Comparator

Arm 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 Title

AD-35 30 mg+Placebo of AD-35 30 mg

Arm Type

Experimental

Arm 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 Title

AD-35 60 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo of AD-35 60mg /AD-35 30mg

Other Intervention Name(s)

Placebo of AD-35

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo of AD-35 60mg /AD-35 60mg

Other Intervention Name(s)

Placebo 60mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AD-35 30 mg + Placebo of AD-35 30 mg

Other Intervention Name(s)

AD-35

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

AD-35 60 mg

Other Intervention Name(s)

AD-35

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11 scores

Description

Changes in the total of ADAS-Cog11 scores of treatment compared with baseline. The score ranged from 0 to 75, and the higher the score, the greater the cognitive impairment

Time Frame

Week 26

Title

Changes in Alzheimer's Disease Cooperative Study-clinical global impression of change (ADCS-CGIC ) scores

Description

Time Frame

Week 26

Secondary Outcome Measure Information:

Title

Changes in ADAS-Cog11 scores

Description

Changes in ADCS-CGIC scores of treatment compared with baseline

Time Frame

Week 6, week 13, week 39, week52

Other Pre-specified Outcome Measures:

Title

Changes in ADCS-CGIC scores

Description

Changes in ADCS-CGIC scores of treatment compared with baseline

Time Frame

Week 6, week 13, week 39, week52

Title

Changes in Mini-mental state examination (MMSE) scores

Description

Changes in MMSE scores of treatment compared with baseline. Each item has a correct score of 1 and an error score of 0.The total score ranges from 0 to 30, and the normal and abnormal boundary values are related to education degree. The lower the boundary value was the cognitive impairment, and the above was normal.

Time Frame

Week 6, week 13, week 26, week 39, week52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianping Jia, PhD

Organizational Affiliation

Xuanwu hospital, capital medical university, Beijing, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Department of Neurosurgery

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100010

Country

China

12. IPD Sharing Statement

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

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