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

A Phase 1 Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02377713

Enrollment

Registered

2015-03-04

Start date

2015-03-31

Completion date

2016-09-30

Last updated

2016-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

KHK6640, Phase 1, Japanese, single dose, Alzheimer's disease

Brief 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.

Interventions

DRUGKHK6640

Single ascending dose administration

DRUGPlacebo

Single ascending dose administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 84 Years

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 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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Up to 90 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026