A Single Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.
- Registration Number
- NCT02377713
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo KHK6640 KHK6640 KHK6640
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability Up to 90 days
- Secondary Outcome Measures
Name Time Method