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

A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in 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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: KHK6640; Drug: Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • UZ Gent, De Pintelaan 185
• Finland
  • Turku, Finland, FI-20520
    • Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B,
• Netherlands
  • Amsterdam, Netherlands, 1081 GM
    • Department of Neurology and Alzheimer Center, VU University Medical Center
  • Groningen, Netherlands, 9700 RB
    • University Medical Centre Groningen (UMCG), Alzheimer Research Centre
• Serbia
  • Belgrade, Serbia, 11 000
    • Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 ,
  • Belgrade, Serbia, 11 000
    • Military Medical Academy, Crnotravska 17,
• Sweden
  • Malmö, Sweden, SE-205 02
    • Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33,
  • Mölndal, Sweden, SE-43141
    • Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6
  • Stockholm, Sweden, SE-141 86
    • Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Matching Placebo; Single ascending dose and multiple ascending doses administration
Experimental: KHK6640	Drug: KHK6640; Single ascending dose and multiple ascending doses administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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	Up to 7 months

Collaborators and Investigators

• Sponsor: Kyowa Hakko Kirin Pharma, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 6640-001; 2013-002873-23 (EudraCT Number)