A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02127476

Enrollment

Registered

2014-04-30

Start date

2014-07-31

Completion date

2017-05-31

Last updated

2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

DRUGKHK6640

Single ascending dose and multiple ascending doses administration

DRUGMatching Placebo

Single ascending dose and multiple ascending doses administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Belgium, Finland, Netherlands, Serbia, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026