Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12613000777796
Ethics application status
Approved
Date submitted
10/07/2013
Date registered
11/07/2013
Date last updated
19/09/2019
Date data sharing statement initially provided
19/09/2019
Date results information initially provided
19/09/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A Phase II Extension study to assess the safety and tolerability of PBT2 and its effect on amyloid levels in the brains of patients with prodromal or mild Alzheimer's disease.
Query!
Scientific title
An Open Label Extension Study to Assess the Safety and Tolerability of PBT2, and its Effect on Amyloid Deposition in the Brains of Patients with Prodromal or Mild Alzheimer's Disease.
Query!
Secondary ID [1]
282731
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PBT2-204-Ext
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prodromal Alzheimer's disease or mild Alzheimer's disease
289465
0
Query!
Condition category
Condition code
Mental Health
289777
289777
0
0
Query!
Other mental health disorders
Query!
Neurological
289778
289778
0
0
Query!
Alzheimer's disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
PBT2 is supplied as 250mg immediate-release capsules. The dose for this study is 250mg / day ie. one capsule is to be taken orally, once a day for 52 weeks duration.
Information on compliance will be collected via a Diary Card and accountability of drug returns. It is also the role of the Study Partner to over-see the daily taking of study drug.
Query!
Intervention code [1]
287394
0
Treatment: Drugs
Query!
Comparator / control treatment
Nil
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
289861
0
To evaluate the safety and tolerability of PBT2 after 52 weeks of treatment as measured by capture of vital signs, physical examination, neurological examination, ECG, eye examination, blood haematology and biochemistry, urinalysis and recording of adverse events.
Possible side effects include tiredness, headache, dizziness, nasopharyingitis and drowsiness.
Query!
Assessment method [1]
289861
0
Query!
Timepoint [1]
289861
0
Baseline, 4, 8, 13, 26, 39 and 52 weeks after commencement of treatment with PBT2 and 4 weeks after cessation of treatment with PBT2
Query!
Primary outcome [2]
289862
0
To evaluate the effect of PBT2 on brain amyloid levels after 52 weeks of treatment as measured by Carbon 11-Pittsburgh Imaging Compound-B (PiB) Positron Emission Tomography (PET) imaging.
Query!
Assessment method [2]
289862
0
Query!
Timepoint [2]
289862
0
52 weeks after commencement of treatment with PBT2.
Query!
Secondary outcome [1]
303405
0
To evaluate the effect of PBT2 on brain metabolic activity after 52 weeks as measured by Fluorine 18 labelled Fluorodeoxyglucose (FDG) PET imaging.
Query!
Assessment method [1]
303405
0
Query!
Timepoint [1]
303405
0
52 weeks after commencement of treatment with PBT2.
Query!
Secondary outcome [2]
303406
0
To evaluate the effect of PBT2 on brain volumes after 52 weeks as assessed by Magnetic Resonance Imaging (MRI) to measure the cortical grey matter volume, hippocampal volume and ventricular volume.
Query!
Assessment method [2]
303406
0
Query!
Timepoint [2]
303406
0
52 weeks after commencement of treatment with PBT2.
Query!
Secondary outcome [3]
303407
0
To evaluate the effect of PBT2 on cognition after 52 weeks as measured by a Neuropsychological Test Battery (NTB) questionnaires and the Mini-mental State Examination (MMSE) questionnaire.
Query!
Assessment method [3]
303407
0
Query!
Timepoint [3]
303407
0
Baseline, 26 and 52 weeks after commencement of treatment with PBT2.
Query!
Secondary outcome [4]
303408
0
To evaluate the effect of PBT2 on functional ability after 52 weeks as measured by the Alzheimer's disease Cooperative Study-Activities of Daily Living-23 (ADCS-ADL-23) questionnaire
Query!
Assessment method [4]
303408
0
Query!
Timepoint [4]
303408
0
Baseline and 52 weeks after commencement of treatment with PBT2.
Query!
Secondary outcome [5]
303409
0
To evaluate the effect of PBT2 on Alzheimer's disease blood biomarkers.
Query!
Assessment method [5]
303409
0
Query!
Timepoint [5]
303409
0
Baseline, 13, 26, 39 and 52 weeks after commencement of treatment with PBT2 and 1 month after cessation of treatment.
Query!
Eligibility
Key inclusion criteria
1. Patients who have completed Visit 10 (Week 52) of the PBT2-204 (IMAGINE) clinical trial [ACTRN12611001008910].
Query!
Minimum age
55
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Allergy to PBT2 or its excipients (microcrystalline cellulose, pregelatinised starch, colloidal silicon dioxide, povidone K29/32 and sodium stearyl fumurate).
2. Have developed any clinically significant uncontrolled medical, ocular or psychiatric illness during PBT2-204.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants enrolled into this Extension study will receive PBT2, regardless of their treatment allocation in the IMAGINE (PBT2-204) clinical trial.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
25/07/2013
Query!
Actual
24/07/2013
Query!
Date of last participant enrolment
Anticipated
31/12/2013
Query!
Actual
3/12/2013
Query!
Date of last data collection
Anticipated
Query!
Actual
8/01/2015
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
33
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
1207
0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Query!
Recruitment hospital [2]
1209
0
Delmont Private Hospital - Glen Iris
Query!
Recruitment hospital [3]
1210
0
Geelong Private Hospital - Geelong
Query!
Recruitment postcode(s) [1]
7069
0
3081 - Heidelberg West
Query!
Recruitment postcode(s) [2]
7071
0
3146 - Glen Iris
Query!
Recruitment postcode(s) [3]
7072
0
3220 - Geelong
Query!
Funding & Sponsors
Funding source category [1]
287559
0
Commercial sector/Industry
Query!
Name [1]
287559
0
Prana Biotechnology Ltd
Query!
Address [1]
287559
0
Level 2, 369 Royal Parade
Parkville VIC 3052
Query!
Country [1]
287559
0
Australia
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
Alterity Therapeutics
Query!
Address
Level 3, 460 Bourke Street, Melbourne, Victoria, 3000,
Query!
Country
Australia
Query!
Secondary sponsor category [1]
286310
0
None
Query!
Name [1]
286310
0
Query!
Address [1]
286310
0
Query!
Country [1]
286310
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
289536
0
Austin Health Human Research Ethics Committee
Query!
Ethics committee address [1]
289536
0
145 Studley Road
Heidelberg VIC 3084
Query!
Ethics committee country [1]
289536
0
Australia
Query!
Date submitted for ethics approval [1]
289536
0
03/06/2013
Query!
Approval date [1]
289536
0
02/07/2013
Query!
Ethics approval number [1]
289536
0
HREC/13/Austin/54
Query!
Summary
Brief summary
This is a Phase II Extension study to examine the safety, tolerability and effect of 52 weeks treatment with PBT2 in patients with prodromal or mild Alzheimer's disease (AD). The primary objectives are to examine the safety and tolerability and the effect of PBT2 on the amount of amyloid in patients brains after 52 weeks of treatment when measured by a particular type of brain scan, PiB-Positron Emission Tomography (PET). The effects of PBT2 on brain volume, brain metabolic activity, blood biomarkers of AD and cognition plus functional abilities will also be investigated.
Query!
Trial website
Query!
Trial related presentations / publications
The hyperlink to the trial publication is:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5702880/
Query!
Public notes
Please note that participation in this Extension study is only open to patients who have participated in the PBT2-204 clinical trial. No new patients will be entered.
Query!
Contacts
Principal investigator
Name
41026
0
A/Prof Michael Woodward
Query!
Address
41026
0
Medical & Cognitive Research Unit Heidelberg Repatriation Hospital 300 Waterdale Road Heidelberg West, VIC 3081
Query!
Country
41026
0
Australia
Query!
Phone
41026
0
+61 (0)3 9496 2852
Query!
Fax
41026
0
Query!
Email
41026
0
[email protected]
Query!
Contact person for public queries
Name
41027
0
Ms Cynthia Wong
Query!
Address
41027
0
Alterity Therapeutics, 39899 Balentine Drive, Suite 360, Newark, CA 94560
Query!
Country
41027
0
United States of America
Query!
Phone
41027
0
+16503002141
Query!
Fax
41027
0
N/A
Query!
Email
41027
0
[email protected]
Query!
Contact person for scientific queries
Name
41028
0
Dr David Stamler
Query!
Address
41028
0
Alterity Therapeutics, 39899 Balentine Drive, Suite 360, Newark, CA 94560
Query!
Country
41028
0
United States of America
Query!
Phone
41028
0
+16503002141
Query!
Fax
41028
0
N/A
Query!
Email
41028
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
The hyperlink to the publication is: https://w...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Redox-Active Metal Ions and Amyloid-Degrading Enzymes in Alzheimer’s Disease
2021
https://doi.org/10.3390/ijms22147697
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF