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

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

This study has been completed.

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

Publications indexed to this study:

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
First Received:	May 8, 2007
Last Updated:	January 13, 2008
ClinicalTrials.gov Identifier:	NCT00471211
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:

Nervous System Diseases

Tauopathies

ClinicalTrials.gov processed this record on October 10, 2008