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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: PBT2	Phase 2

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
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
Study Start Date :	December 2006
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Safety [ Time Frame: Study duration ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	56 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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, 3081
Melbourne, Victoria, Australia, 3101
Melbourne, Victoria, Australia, 3146
Melbourne, Victoria, Australia, 3199
Sweden
Falkoping, Sweden, 521 85
Kalix, Sweden, 952 81
Kalmar, Sweden, 391 85
Lund, Sweden, 85
Malmo, Sweden, 205 20
Stockholm, Sweden, 112 98
Umea, Sweden, 901 85
Uppsala, Sweden, 751 85

Sponsors and Collaborators

Prana Biotechnology Limited

Investigators

Principal Investigator:	Lars Lannfelt, Professor	Uppsala University Hospital, Sweden

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1016/S1474-4422(08)70167-4. Epub 2008 Jul 30. Erratum in: Lancet Neurol. 2009 Nov;8(11):981.

ClinicalTrials.gov Identifier:	NCT00471211 History of Changes
Other Study ID Numbers:	PBT2-201
First Posted:	May 9, 2007
Last Update Posted:	January 16, 2008
Last Verified:	January 2008

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders