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KHK6640 Phase I study (A single dose study in patients with Alzheimer's disease)

KHK6640 Phase I study (A single dose study in patients with Alzheimer's disease)

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222766
Enrollment
20
Registered
2015-02-26
Start date
2015-02-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Alzheimers disease

Interventions

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients with mild to moderate AD - Body weight >= 40 kg and = 17 and =< 26

Exclusion criteria

Exclusion criteria: - Previous active treatment with an AD immunotherapy in an investigational study - Use of another investigational drug within 4 months 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 who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD - Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD

Design outcomes

Primary

MeasureTime frame
Safety Safety (adverse events)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026