A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease

6640-001

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.

2014-07-01

2017-05-01

2017-05-01

Completed

Early phase I

57

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 57, 'type': 'ACTUAL'}}

2024-06-17