search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
KHK6640
Matching Placebo
Sponsored by
Kyowa Hakko Kirin Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Gent, De Pintelaan 185
  • Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B,
  • Department of Neurology and Alzheimer Center, VU University Medical Center
  • University Medical Centre Groningen (UMCG), Alzheimer Research Centre
  • Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 ,
  • Military Medical Academy, Crnotravska 17,
  • Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33,
  • Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6
  • Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KHK6640

Placebo

Arm Description

KHK6640

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 24, 2014
Last Updated
May 31, 2017
Sponsor
Kyowa Hakko Kirin Pharma, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02127476
Brief Title
A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease
Official Title
A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Hakko Kirin Pharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHK6640
Arm Type
Experimental
Arm Description
KHK6640
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
KHK6640
Intervention Description
Single ascending dose and multiple ascending doses administration
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Single ascending dose and multiple ascending doses administration
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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
Time Frame
Up to 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UZ Gent, De Pintelaan 185
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B,
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Facility Name
Department of Neurology and Alzheimer Center, VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081 GM
Country
Netherlands
Facility Name
University Medical Centre Groningen (UMCG), Alzheimer Research Centre
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 ,
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Military Medical Academy, Crnotravska 17,
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33,
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6
City
Mölndal
ZIP/Postal Code
SE-43141
Country
Sweden
Facility Name
Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs