NCT02377713
Completed
Phase 1
A Phase 1 Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.
Overview
- Phase
- Phase 1
- Intervention
- KHK6640
- Conditions
- Alzheimer's Disease
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 20
- Primary Endpoint
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's Disease.
Investigators
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 4 months 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
Arms & Interventions
KHK6640
KHK6640
Intervention: KHK6640
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 90 days
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