A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: KHK6640; Drug: Placebo

• Registration Number: NCT03093519
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's Disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-03
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Primary Completion: 2017-12-06
• Study Completion: 2017-12-06
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-18
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patients with mild to moderate Alzheimer's Disease
• Body weight ≥ 40 kg and < 100 kg
• Clinical Dementia Rating (CDR) score of 1 or 2
• Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26

Exclusion Criteria

• Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study
• Use of another investigational drug within 16 weeks prior to the enrollment
• Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
• Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
• Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease
• Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KHK6640	KHK6640	Intravenous administration
Placebo	Placebo	Intravenous administration

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Up to 197days after first dosing	Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Trial Locations

Locations (1)

Closed information; 🇯🇵 Saitama, Japan