A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease
NCT ID: NCT03093519
Last Updated: 2018-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2017-03-03
2017-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KHK6640
Intravenous administration
KHK6640
Intravenous administration
Placebo
Intravenous administration
Placebo
Intravenous administration
Interventions
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KHK6640
Intravenous administration
Placebo
Intravenous administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
84 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Closed information
Saitama, , Japan
Countries
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Other Identifiers
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6640-003
Identifier Type: -
Identifier Source: org_study_id
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