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

Kyowa Kirin

Status and phase

Completed

Phase 1

Conditions

Alzheimer Disease

Treatments

Drug: Placebo

Drug: KHK6640

Study type

Interventional

Funder types

Industry

Identifiers

NCT03093519

6640-003

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

55 to 84 years old

Volunteers

No Healthy Volunteers

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