A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease

• Status: Completed
• Trial end date: 2017-05-01
• 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 and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.

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

Details

• Lead Sponsor: Kyowa Hakko Kirin Pharma, Inc.

Criteria

Inclusion Criteria:

• Patients with prodromal AD or mild to moderate AD

• Clinical Dementia Rating (CDR) score of 0.5, 1.0, or 2.0

• Have a cognitive impairment

• Low Aβ and high Tau in Cerebrospinal fluid (CSF)

• Mini Mental State Examination (MMSE) score > 16 at Screening

Exclusion Criteria:

• Previous active treatment with an AD immunotherapy in an investigational study

• Use of another investigational drug within 30 days of screening

• History or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease

• Presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD

• Evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD