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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03790982
Recruitment Status : Active, not recruiting
First Posted : January 2, 2019
Last Update Posted : January 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Placebo of AD-35 60mg /AD-35 30mg Drug: Placebo of AD-35 60mg /AD-35 60mg Drug: AD-35 30 mg + Placebo of AD-35 30 mg Drug: AD-35 60 mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment, Multiple Groups, Multiple Centers
Masking: Double (Participant, Investigator)
Masking Description: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo of AD-35 60mg /AD-35 30mg
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)
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.
Other Name: Placebo of AD-35

Placebo Comparator: Placebo of AD-35 60mg /AD-35 60mg
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)
Drug: Placebo of AD-35 60mg /AD-35 60mg
Placebo 60mg, oral, 1st 26 weeks; AD-35 60mg oral, 2nd 26 weeks.
Other Name: Placebo 60mg

Experimental: 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, once daily for 52 weeks (oral)
Drug: 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.
Other Name: AD-35

Experimental: AD-35 60 mg
AD-35 60 mg AD-35 30 mg× two tablets, once daily for 52 weeks (oral)
Drug: AD-35 60 mg
AD-35 60 mg AD-35 30 mg x two tablets, oral, 52 weeks.
Other Name: AD-35




Primary Outcome Measures :
  1. Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11 scores [ Time Frame: Week 26 ]
    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

  2. Changes in Alzheimer's Disease Cooperative Study-clinical global impression of change (ADCS-CGIC ) scores [ Time Frame: Week 26 ]
    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 :
  1. Changes in ADAS-Cog11 scores [ Time Frame: Week 6, week 13, week 39, week52 ]
    Changes in ADCS-CGIC scores of treatment compared with baseline


Other Outcome Measures:
  1. Changes in ADCS-CGIC scores [ Time Frame: Week 6, week 13, week 39, week52 ]
    Changes in ADCS-CGIC scores of treatment compared with baseline

  2. Changes in Mini-mental state examination (MMSE) scores [ Time Frame: Week 6, week 13, week 26, week 39, week52 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790982


Locations
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China, Beijing
The Department of Neurosurgery
Beijing, Beijing, China, 100010
Sponsors and Collaborators
Zhejiang Hisun Pharmaceutical Co. Ltd.
Investigators
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Principal Investigator: Jianping Jia, PhD Xuanwu hospital, capital medical university, Beijing, China
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Responsible Party: Zhejiang Hisun Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT03790982    
Other Study ID Numbers: AD-35-II-01
First Posted: January 2, 2019    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhejiang Hisun Pharmaceutical Co. Ltd.:
AD-35 tablet
Alzheimer's Disease
Phase II study
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders