Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease

This study has been completed.

First Received: May 8, 2007 Last Updated: January 13, 2008 History of Changes

Sponsored by:	Prana Biotechnology Limited
Information provided by:	Prana Biotechnology Limited
ClinicalTrials.gov Identifier:	NCT00471211

Purpose

The purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of PBT2 administered for 12 weeks compared to placebo in patients with early Alzheimer's disease treated with an acetylcholinesterase inhibitor.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: PBT2	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Three-Group Study to Assess the Safety, Tolerability and Efficacy of Two Dose Levels of PBT2 to Slow Progression of Disease in Patients With Early Alzheimer's Disease

Further study details as provided by Prana Biotechnology Limited:

Primary Outcome Measures:

Safety [ Time Frame: Study duration ]

Secondary Outcome Measures:

Change from baseline in biomarkers; Change from baseline in cognitive and global function scales [ Time Frame: Study duration ]

Estimated Enrollment:	80
Study Start Date:	December 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	56 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of probable early Alzheimer's disease
stable dose of acetylcholinesterase inhibitor
community dwelling
stable medical condition

Exclusion Criteria:

unstable and significant medical conditions
recurrent major psychiatric disorder
treatment with memantine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471211

Locations

Australia, New South Wales

Sydney, New South Wales, Australia, 2031

Sydney, New South Wales, Australia, 2077
Australia, South Australia

Adelaide, South Australia, Australia, 5011
Australia, Victoria

Melbourne, Victoria, Australia, 3199

Melbourne, Victoria, Australia, 3081

Melbourne, Victoria, Australia, 3146

Melbourne, Victoria, Australia, 3101
Sweden

Kalix, Sweden, 952 81

Umea, Sweden, 901 85

Stockholm, Sweden, 112 98

Malmo, Sweden, 205 20

Falkoping, Sweden, 521 85

Uppsala, Sweden, 751 85

Kalmar, Sweden, 391 85

Lund, Sweden, 85

Sponsors and Collaborators

Prana Biotechnology Limited

Investigators

Principal Investigator:

Lars Lannfelt, Professor

Uppsala University Hospital, Sweden

More Information

No publications provided by Prana Biotechnology Limited

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lannfelt L, Blennow K, Zetterberg H, Batsman S, Ames D, Harrison J, Masters CL, Targum S, Bush AI, Murdoch R, Wilson J, Ritchie CW; PBT2-201-EURO study group. Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer's disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2008 Sep;7(9):779-86. Epub 2008 Jul 30.

Study ID Numbers:	PBT2-201
Study First Received:	May 8, 2007
Last Updated:	January 13, 2008
ClinicalTrials.gov Identifier:	NCT00471211 History of Changes
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

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

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

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

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009