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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00471211




Registration number
NCT00471211
Ethics application status
Date submitted
8/05/2007
Date registered
9/05/2007
Date last updated
16/01/2008

Titles & IDs
Public title
Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease
Scientific 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
Secondary ID [1] 0 0
PBT2-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
Study duration
Secondary outcome [1] 0 0
Change from baseline in biomarkers; Change from baseline in cognitive and global function scales
Timepoint [1] 0 0
Study duration

Eligibility
Key inclusion criteria
* diagnosis of probable early Alzheimer's disease
* stable dose of acetylcholinesterase inhibitor
* community dwelling
* stable medical condition
Minimum age
56 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* unstable and significant medical conditions
* recurrent major psychiatric disorder
* treatment with memantine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
2077 - Sydney
Recruitment postcode(s) [3] 0 0
5011 - Adelaide
Recruitment postcode(s) [4] 0 0
3081 - Melbourne
Recruitment postcode(s) [5] 0 0
3101 - Melbourne
Recruitment postcode(s) [6] 0 0
3146 - Melbourne
Recruitment postcode(s) [7] 0 0
3199 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Sweden
State/province [1] 0 0
Falkoping
Country [2] 0 0
Sweden
State/province [2] 0 0
Kalix
Country [3] 0 0
Sweden
State/province [3] 0 0
Kalmar
Country [4] 0 0
Sweden
State/province [4] 0 0
Lund
Country [5] 0 0
Sweden
State/province [5] 0 0
Malmo
Country [6] 0 0
Sweden
State/province [6] 0 0
Stockholm
Country [7] 0 0
Sweden
State/province [7] 0 0
Umea
Country [8] 0 0
Sweden
State/province [8] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prana Biotechnology Limited
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00471211
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Lars Lannfelt, Professor
Address 0 0
Uppsala University Hospital, Sweden
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00471211