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

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

KHK6640

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring KHK6640, Phase 1, Japanese, single dose, Alzheimer's disease

Eligibility Criteria

55 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KHK6640

Placebo

Arm Description

KHK6640

Placebo

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary Outcome Measures

Full Information

NCT ID

NCT02377713

First Posted

February 25, 2015

Last Updated

December 6, 2016

Sponsor

Kyowa Kirin Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02377713

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

KHK6640, Phase 1, Japanese, single dose, Alzheimer's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KHK6640

Arm Type

Experimental

Arm Description

KHK6640

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

KHK6640

Intervention Description

Single ascending dose administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single ascending dose administration

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame

Up to 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Tokyo

State/Province

Sumida-ku

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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