NCT02127476

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2014

Typical duration for phase_1

Geographic Reach
4 countries

7 active sites

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

April 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

2.8 years

First QC Date

April 24, 2014

Last Update Submit

June 14, 2024

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

KHK6640

EXPERIMENTAL

KHK6640

Drug: KHK6640

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Matching Placebo

Interventions

KHK6640DRUG

Single ascending dose and multiple ascending doses administration

KHK6640
Matching PlaceboDRUG

Single ascending dose and multiple ascending doses administration

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 Aβ and high Tau in Cerebrospinal fluid (CSF)
  • Mini Mental State Examination (MMSE) score \> 16 at Screening

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UZ Gent, De Pintelaan 185

Ghent, 9000, Belgium

Location

Clinical Research Services Turku (CRST), Itäinen Pitkäkatu 4B,

Turku, FI-20520, Finland

Location

Department of Neurology and Alzheimer Center, VU University Medical Center

Amsterdam, 1081 GM, Netherlands

Location

University Medical Centre Groningen (UMCG), Alzheimer Research Centre

Groningen, 9700 RB, Netherlands

Location

Clinical Centre of Serbia, Neurology Clinic, Dr Subotica Starijeg 6 ,

Belgrade, 11 000, Serbia

Location

Military Medical Academy, Crnotravska 17,

Belgrade, 11 000, Serbia

Location

Memory Clinic, Malmo Minneskliniken, Memory Research Unit, Hs 33,

Malmo, SE-205 02, Sweden

Location

Sahlgrenska Gothenburg, Minnesmottagningen, Wallinsgatan 6

Mölndal, SE-43141, Sweden

Location

Karolinska Stockholm Karolinska University Hospital, Huddinge, Dept. of Geriatrics/Memory Disorders Unit

Stockholm, SE-141 86, Sweden

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 30, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 17, 2024

Record last verified: 2024-06

Locations

SE(3)BE(1)FI(1)NL(2)