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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377713
• Other study ID #: 6640-002
• Status: Completed
• Phase: Phase 1
• First received: February 25, 2015
• Last updated: December 6, 2016
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 84 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• KHK6640
Single ascending dose administration
• Placebo
Single ascending dose administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Up to 90 days	Yes