Alzheimer Disease
Conditions
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.
Interventions
DRUGKHK6640
Intravenous administration
DRUGPlacebo
Intravenous administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | Up to 197days after first dosing | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Countries
Japan
Outcome results
None listed