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COMPLETEDPHASE1

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

A Phase 1 Randomized, Double-blind, Placebo-controlled, Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease

NCT03093519•Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

55 - 84 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Closed information

Saitama, Japan

Key Dates

Start Date

March 3, 2017

Primary Completion Date

December 6, 2017

Completion Date

December 6, 2017

Last Updated

March 20, 2018

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

KHK6640

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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