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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
Single ascending dose and multiple ascending doses administration
Single ascending dose and multiple ascending doses administration
UZ Gent, De Pintelaan 185
Ghent, Belgium
Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B,
Turku, Finland
Department of Neurology and Alzheimer Center, VU University Medical Center
Amsterdam, Netherlands
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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
Time frame: Up to 7 months
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University Medical Centre Groningen (UMCG), Alzheimer Research Centre
Groningen, Netherlands
Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 ,
Belgrade, Serbia
Military Medical Academy, Crnotravska 17,
Belgrade, Serbia
Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33,
Malmo, Sweden
Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6
Mölndal, Sweden
Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit
Stockholm, Sweden