NCT02377713

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

1.5 years

First QC Date

February 25, 2015

Last Update Submit

December 6, 2016

Conditions

Alzheimer's Disease

Keywords

KHK6640Phase 1Japanesesingle doseAlzheimer's disease

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Up to 90 days

Study Arms (2)

KHK6640

EXPERIMENTAL

KHK6640

Drug: KHK6640

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

KHK6640DRUG

Single ascending dose administration

KHK6640
PlaceboDRUG

Single ascending dose administration

Placebo

Eligibility Criteria

Age55 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Sumida-ku, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental 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

February 25, 2015

First Posted

March 4, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

JP(1)