A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127476
• Other study ID #: 6640-001
• Secondary ID: 2013-002873-23
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: May 2017

Study information

• Verified date: June 2024
• Source: Kyowa 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 single dose and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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 Aß 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• KHK6640
Single ascending dose and multiple ascending doses administration
• Matching Placebo
Single ascending dose and multiple ascending doses administration

Locations

Country	Name	City	State
Belgium	UZ Gent, De Pintelaan 185	Gent
Finland	Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B,	Turku
Netherlands	Department of Neurology and Alzheimer Center, VU University Medical Center	Amsterdam
Netherlands	University Medical Centre Groningen (UMCG), Alzheimer Research Centre	Groningen
Serbia	Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 ,	Belgrade
Serbia	Military Medical Academy, Crnotravska 17,	Belgrade
Sweden	Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33,	Malmö
Sweden	Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6	Mölndal
Sweden	Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.	Kyowa Hakko Kirin Pharma, Inc.

Countries where clinical trial is conducted

Belgium,  Finland,  Netherlands,  Serbia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs, laboratory parameters (hematology, chemistry, and urinalysis), vital signs, 12-lead electrocardiograms, physical and neurological examinations, and brain MRI	Up to 7 months