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CompletedPhase 1

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

Asset

KHK6640

Listed sites

9

Recruiting sites

-

Enrollment

57

actual

Study population

Alzheimer’s disease

Key I/E criteria

•prodromal AD / mild-to-moderate AD•MMSE ≥16

Primary endpoint

•Adverse Events as a Measure of Safety and Tolerability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2013-002873-23
Org study ID6640-001
NCT IDNCT02127476

Timeline

Milestones

Study first posted2014-04-30estimated
Study start2014-07 (month precision)
Primary completion2017-05actual (month precision)
Study completion2017-05actual (month precision)
Last update posted2024-06-17actual

Assets

Drug assets

KHK6640

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Neuroimaging

1 endpoint
Primary/protocol endpoint

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame:Up to 7 months

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.