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

NCT03625401 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-03-25

No results posted yet for this study

Summary

multi-center, randomized, double-blind, parallel-group,placebo-controlled study to evaluate the safety and tolerability, efficacy, and PK of 60 mg AD-35 administered QD during 6 months of double-blind treatment followed by a second 6 months of open-label treatment to subjects with mild to moderate AD.

Conditions

  • Alzheimer Disease, Early Onset

Interventions

DRUG

AD-35 60mg group

AD-35 60mg QD

DRUG

Placebo group

Placebo: 3 placebo of AD-35 30mg tablets

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Rentian (Roy) Feng, PhD · Zhejiang Hisun Pharmaceuticals Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03625401 on ClinicalTrials.gov