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
1 other identifier
interventional
80
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2006
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 8, 2007
CompletedFirst Posted
Study publicly available on registry
May 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJanuary 16, 2008
January 1, 2008
1 year
May 8, 2007
January 13, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
Study duration
Secondary Outcomes (1)
Change from baseline in biomarkers; Change from baseline in cognitive and global function scales
Study duration
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of probable early Alzheimer's disease
- stable dose of acetylcholinesterase inhibitor
- community dwelling
- stable medical condition
You may not qualify if:
- unstable and significant medical conditions
- recurrent major psychiatric disorder
- treatment with memantine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Sydney, New South Wales, 2031, Australia
Unknown Facility
Sydney, New South Wales, 2077, Australia
Unknown Facility
Adelaide, South Australia, 5011, Australia
Unknown Facility
Melbourne, Victoria, 3081, Australia
Unknown Facility
Melbourne, Victoria, 3101, Australia
Unknown Facility
Melbourne, Victoria, 3146, Australia
Unknown Facility
Melbourne, Victoria, 3199, Australia
Unknown Facility
Falköping, 521 85, Sweden
Unknown Facility
Kalix, 952 81, Sweden
Unknown Facility
Kalmar, 391 85, Sweden
Unknown Facility
Lund, 85, Sweden
Unknown Facility
Malmo, 205 20, Sweden
Unknown Facility
Stockholm, 112 98, Sweden
Unknown Facility
Umeå, 901 85, Sweden
Unknown Facility
Uppsala, 751 85, Sweden
Related Publications (1)
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.
PMID: 18672400DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Lannfelt, Professor
Uppsala University Hospital, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2007
First Posted
May 9, 2007
Study Start
December 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
January 16, 2008
Record last verified: 2008-01