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.
Who can participate
Age range55 Years
SexALL
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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
What they're measuring
1
Number of Participants with Adverse Events as a Measure of Safety and Tolerability