Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007287

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007287
  •   2015/08/04
  •   2014/04/24
  •   no
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Secondary IDs

  •   2013-002873-23 
  •   NCT02127476  (ClinicalTrials.gov)
  •   6640-001  (Kyowa Hakko Kirin Pharma, Inc.)
  •   2013-002873-23 
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Health Condition or Problem studied

  •   Alzheimer's Disease
  •   G30 -  Alzheimer disease
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Interventions/Observational Groups

  •   Drug: KHK6640
  •   Drug: Matching Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   I
  •   [---]*
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Primary Outcome

- Number of Participants with Adverse Events as a Measure of Safety and Tolerability; time frame: Up to 7 months; 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

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Secondary Outcome

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Countries of Recruitment

  •   Belgium
  •   Finland
  •   Germany
  •   Netherlands
  •   Sweden
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   [---]*
  •   2014/07/31
  •   62
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   no maximum age
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Additional 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 Aβ and high Tau in Cerebrospinal fluid (CSF)

- Mini Mental State Examination (MMSE) score > 16 at Screening

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Kyowa Hakko Kirin Pharma, Inc.
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    •   [---]*
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    • Project Leader 
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    end of 1:1-Block address contact scientific-contact
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    • Project Leader 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.