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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Co., Ltd; Kyowa Kirin Co., Ltd.

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