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

NCT ID: NCT02377713

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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KHK6640 Phase 1 Japanese single dose Alzheimer's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KHK6640

KHK6640

Group Type EXPERIMENTAL

KHK6640

Intervention Type DRUG

Single ascending dose administration

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single ascending dose administration

Interventions

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KHK6640

Single ascending dose administration

Intervention Type DRUG

Placebo

Single ascending dose administration

Intervention Type DRUG

Eligibility Criteria

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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 4 months 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
Minimum Eligible Age

55 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo, Sumida-ku, Japan

Site Status

Countries

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Japan

Other Identifiers

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6640-002

Identifier Type: -

Identifier Source: org_study_id