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

Alzheimer's Disease Clinical Trial

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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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03790982
• Other study ID #: AD-35-II-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 1, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: December 2018
• Source: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: July 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Placebo of AD-35 60mg /AD-35 30mg
Placebo 60mg, oral, 1st 26 weeks; AD-35 30mg +Placebo of AD-35 30mg oral 2nd 26 weeks.
• Placebo of AD-35 60mg /AD-35 60mg
Placebo 60mg, oral, 1st 26 weeks; AD-35 60mg oral, 2nd 26 weeks.
• AD-35 30 mg + Placebo of AD-35 30 mg
AD-35 30 mg + Placebo of AD-35 30 mg AD-35 30 mg + Placebo of AD-35 30 mg, Oral, 52 weeks.
• AD-35 60 mg
AD-35 60 mg AD-35 30 mg x two tablets, oral, 52 weeks.

Locations

Country	Name	City	State
China	The Department of Neurosurgery	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Hisun Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in ADCS-CGIC scores	Changes in ADCS-CGIC scores of treatment compared with baseline	Week 6, week 13, week 39, week52
Other	Changes in Mini-mental state examination (MMSE) scores	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.	Week 6, week 13, week 26, week 39, week52
Primary	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	Week 26
Primary	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.	Week 26
Secondary	Changes in ADAS-Cog11 scores	Changes in ADCS-CGIC scores of treatment compared with baseline	Week 6, week 13, week 39, week52