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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093519
• Other study ID #: 6640-003
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2017
• Last updated: March 18, 2018
• Start date: March 3, 2017
• Est. completion date: December 6, 2017

Study information

• Verified date: March 2018
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's Disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 6, 2017
• Est. primary completion date: December 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• KHK6640
Intravenous administration
• Placebo
Intravenous administration

Locations

Country	Name	City	State
Japan	Closed information	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Up to 197days after first dosing