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

This study has been completed.

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00083421

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 II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Arundic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of ONO-2506PO in Patients With Alzheimer's Disease

Further study details as provided by Ono Pharma:

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 88 Study Locations

Sponsors and Collaborators

Ono Pharma

More Information

Study ID Numbers:	ONO-2506POU010
Study First Received:	May 24, 2004
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00083421
Health Authority:	United States: Food and Drug Administration; Canada: Therapeutic Products Division

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 15, 2009