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

NCT03093519 | Completed Phase 1

• 1 other identifier: 6640-003
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

KHK6640

EXPERIMENTAL

Intravenous administration

Drug: KHK6640

Placebo

PLACEBO COMPARATOR

Intravenous administration

Drug: Placebo

Interventions

KHK6640 DRUG

Intravenous administration

KHK6640

Placebo DRUG

Intravenous administration

Placebo

Eligibility Criteria

• Age: 55 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Closed information

Saitama, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: March 3, 2017
• Primary Completion: December 6, 2017
• Study Completion: December 6, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)