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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00083421
Recruitment Status : Completed
First Posted : June 18, 2004
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ONO-2506PO Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 647 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of ONO-2506PO in Patients With Alzheimer's Disease
Study Start Date : June 2004
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Cognitive Function Scale
  2. Global Function Scale

Secondary Outcome Measures :
  1. ADL Scale
  2. Psychiatric Symptom Scale

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083421

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

Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT00083421     History of Changes
Other Study ID Numbers: ONO-2506POU010
First Posted: June 18, 2004    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders