Back to resultsA Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
KHK6640
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
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
Sites / Locations
- Closed information
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KHK6640
Placebo
Arm Description
Intravenous administration
Intravenous administration
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03093519
Brief Title
A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease
Official Title
A Phase 1 Randomized, Double-blind, Placebo-controlled, Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
December 6, 2017 (Actual)
Study Completion Date
December 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK6640
Arm Type
Experimental
Arm Description
Intravenous administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous administration
Intervention Type
Drug
Intervention Name(s)
KHK6640
Intervention Description
Intravenous administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous administration
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Up to 197days after first dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Closed information
City
Saitama
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease
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