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

Kyowa Kirin

Status and phase

Completed

Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: Matching Placebo

Drug: KHK6640

Study type

Interventional

Funder types

Industry

Identifiers

NCT02127476

2013-002873-23 (EudraCT Number)

6640-001

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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