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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014