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CompletedPhase 1

A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease

A Phase 1 Randomized, Double-blind, Placebo-controlled, Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease

Asset

KHK6640

Listed sites

1

Recruiting sites

-

Enrollment

21

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 17-26

Primary endpoint

•Adverse Events

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

Org study ID6640-003
NCT IDNCT03093519

Timeline

Milestones

Study start2017-03-03actual
Study first posted2017-03-28actual
Primary completion2017-12-06actual
Study completion2017-12-06actual
Last update posted2018-03-20actual

Assets

Drug assets

KHK6640

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age84 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Patients with mild to moderate Alzheimer's Disease
•Body weight ≥ 40 kg and < 100 kg
•Clinical Dementia Rating (CDR) score of 1 or 2
•Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26

Exclusion criteria

•Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study
•Use of another investigational drug within 16 weeks prior to the enrollment
•Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
•Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
•Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease
•Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease

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.

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Participants with Adverse Events

Time frame:Up to 197days after first dosing

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.