Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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