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Effects of ONO-2506PO in Patients With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT00083421
First received: May 24, 2004
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to establish the presence of an effect of treatment with ONO-2506PO in patients with Alzheimer's Disease, based upon cognitive and global scales.


Condition Intervention Phase
Alzheimer's Disease
 Drug: ONO-2506PO
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of ONO-2506PO in Patients With Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Cognitive Function Scale
  • Global Function Scale

Secondary Outcome Measures:
  • ADL Scale
  • Psychiatric Symptom Scale

Enrollment: 647
Study Start Date: June 2004
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease using NINCDS/ADRDA criteria
  • Standardized MMSE Score of 13 to 24 points (inclusive)
  • Modified Hachinski score equal or less than 4

Exclusion Criteria:

  • Serious systemic disease that may preclude survival to study completion
  • Other illnesses that may include dementive features
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083421

  Show 87 Study Locations
Sponsors and Collaborators
Ono Pharma USA Inc
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT00083421     History of Changes
Other Study ID Numbers: ONO-2506POU010
Study First Received: May 24, 2004
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013