Overview

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

Status:
Completed
Trial end date:
2017-12-06
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 repeated 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 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