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

This study has been completed.
Sponsor:
Information provided by:
Prana Biotechnology Limited
ClinicalTrials.gov Identifier:
NCT00471211
First received: May 8, 2007
Last updated: January 13, 2008
Last verified: January 2008
History of Changes
May 8, 2007
January 13, 2008
December 2006
December 2007   (Final data collection date for primary outcome measure)
Safety [ Time Frame: Study duration ]
Same as current
Complete list of historical versions of study NCT00471211 on ClinicalTrials.gov Archive Site
Change from baseline in biomarkers; Change from baseline in cognitive and global function scales [ Time Frame: Study duration ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer's Disease
Drug: PBT2
Not Provided
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.
 
Completed
80
December 2007
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
56 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Sweden
 
 
NCT00471211
PBT2-201
Yes
Not Provided
Not Provided
Not Provided
Prana Biotechnology Limited
Not Provided
Principal Investigator: Lars Lannfelt, Professor Uppsala University Hospital, Sweden
Prana Biotechnology Limited
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP