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

Tracking Information
First Submitted Date ICMJE	May 8, 2007
First Posted Date ICMJE	May 9, 2007
Last Update Posted Date	January 16, 2008
Study Start Date ICMJE	December 2006
Actual Primary Completion Date	December 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 8, 2007)	Safety [ Time Frame: Study duration ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00471211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 8, 2007)	Change from baseline in biomarkers; Change from baseline in cognitive and global function scales [ Time Frame: Study duration ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease
Official Title ICMJE	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
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Alzheimer's Disease
Intervention ICMJE	Drug: PBT2
Study Arms	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: May 8, 2007)	80
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2007
Actual Primary Completion Date	December 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	56 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Sweden
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00471211
Other Study ID Numbers ICMJE	PBT2-201
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Prana Biotechnology Limited
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Lars Lannfelt, Professor Uppsala University Hospital, Sweden
PRS Account	Prana Biotechnology Limited
Verification Date	January 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP