A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT02127476
- 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 and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KHK6640 KHK6640 KHK6640 Placebo Matching Placebo Placebo
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Department of Neurology and Alzheimer Center, VU University Medical Center
🇳🇱Amsterdam, Netherlands
University Medical Centre Groningen (UMCG), Alzheimer Research Centre
🇳🇱Groningen, Netherlands
UZ Gent, De Pintelaan 185
🇧🇪Gent, Belgium
Military Medical Academy, Crnotravska 17,
🇷🇸Belgrade, Serbia
Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B,
🇫🇮Turku, Finland
Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33,
🇸🇪Malmö, Sweden
Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 ,
🇷🇸Belgrade, Serbia
Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit
🇸🇪Stockholm, Sweden
Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6
🇸🇪Mölndal, Sweden