NCT02127476CompletedPhase 1
A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 57
- Locations
- 9
- Primary Endpoint
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with prodromal AD or mild to moderate AD
- •Clinical Dementia Rating (CDR) score of 0.5, 1.0, or 2.0
- •Have a cognitive impairment
- •Low Aβ and high Tau in Cerebrospinal fluid (CSF)
- •Mini Mental State Examination (MMSE) score > 16 at Screening
Exclusion Criteria
- •Previous active treatment with an AD immunotherapy in an investigational study
- •Use of another investigational drug within 30 days of screening
- •History or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
- •Presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD
- •Evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD
Arms & Interventions
KHK6640
Experimental
KHK6640
Intervention: KHK6640 (Drug)
Placebo
Placebo Comparator
Placebo
Intervention: Matching Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 7 months
Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs, laboratory parameters (hematology, chemistry, and urinalysis), vital signs, 12-lead electrocardiograms, physical and neurological examinations, and brain MRI
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (9)
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