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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02127476
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: KHK6640 Drug: Matching Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease
Study Start Date : July 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: KHK6640
Drug: KHK6640
Single ascending dose and multiple ascending doses administration

Placebo Comparator: Placebo
Drug: Matching Placebo
Single ascending dose and multiple ascending doses administration

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02127476

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

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Responsible Party: Kyowa Hakko Kirin Pharma, Inc. Identifier: NCT02127476    
Other Study ID Numbers: 6640-001
2013-002873-23 ( EudraCT Number )
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders