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Completed

NCT Number: NCT03093519

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Closed information

Saitama, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KHK6640

Drug

Intravenous administration

Placebo

Drug

Intravenous administration

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Up to 197days after first dosing

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 28, 2017
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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