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Completed

NCT Number: NCT02127476

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

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.

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Key information

Conditions

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

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UZ Gent, De Pintelaan 185, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

KHK6640

Drug

Single ascending dose and multiple ascending doses administration

Matching Placebo

Drug

Single ascending dose and multiple ascending doses administration

Primary outcomes

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

    Time frame: Up to 7 months

    Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs, laboratory parameters (hematology, chemistry, and urinalysis), vital signs, 12-lead electrocardiograms, physical and neurological examinations, and brain MRI

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Collaborators

  • Kyowa Hakko Kirin Pharma, Inc.

Registry information

Official study title

A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 30, 2014
Registry last updated
Jun 17, 2024

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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