LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
Download to PDF
Trial registered on ANZCTR
Trial ID
ACTRN12611001008910
Ethics application status
Approved
Date submitted
17/09/2011
Date registered
20/09/2011
Date last updated
31/03/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
A Phase II clinical trial 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
A Randomised, Double-Blind, Placebo Controlled 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]
262995
0
Nil
Query!
Universal Trial Number (UTN)
U1111-1124-2486
Query!
Trial acronym
PBT2-204 / IMAGINE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prodromal Alzheimer's disease or mild Alzheimer's disease
270699
0
Query!
Condition category
Condition code
Mental Health
270873
270873
0
0
Query!
Other mental health disorders
Query!
Neurological
271010
271010
0
0
Query!
Dementias
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.
Query!
Intervention code [1]
269318
0
Treatment: drugs
Query!
Comparator / control treatment
Placebo is supplied as identical looking, immediate-release capsules. One capsule is to be taken orally, once a day for 52 weeks duration.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
279555
0
To evaluate the effect of PBT2 compared to placebo 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!
Timepoint [1]
279555
0
Baseline, 26 and 52 weeks after commencement of treatment with PBT2/placebo
Query!
Secondary outcome [1]
287893
0
To evaluate the safety and tolerability of PBT2 compared to placebo as measured by capture of vital signs, physical examination, neurological examination, ECG, eye examination, blood haematology and biochemistry, urinalysis and recording of adverse events.
From previous clinical trials, the most commonly reported side effects that were possibly related to PBT2 were fatigue (tiredness), headache, dizziness, nasopharyngitis (swollen blocked nose), and somnolence (drowsiness). Less common side-effects possibly related to PBT2 were diarrhoea, back pain, nausea and pharyngolaryngeal (throat) pain. It is possible that a rare side effect may be dissociation (a feeling of disconnecting from one's thoughts, feelings, memories or self).
Query!
Timepoint [1]
287893
0
Baseline, 4, 8, 13, 19, 26, 33, 39, 45 and 52 weeks after commencement of treatment with PBT2/placebo and 4 weeks after cessation of treatment with PBT2/placebo
Query!
Secondary outcome [2]
287894
0
To evaluate the effect of PBT2 compared to placebo on brain metabolic activity after 52 weeks as measured by Fluorine 18 labelled Fluorodeoxyglucose (FDG) PET imaging.
Query!
Timepoint [2]
287894
0
Baseline and 52 weeks after commencement of of treatment withPBT2/placebo
Query!
Secondary outcome [3]
287895
0
To evaluate the effect of PBT2 compared to placebo 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!
Timepoint [3]
287895
0
Baseline and 52 weeks after commencement of of treatment withPBT2/placebo
Query!
Secondary outcome [4]
287896
0
To evaluate the effect of PBT2 compared to placebo on cognition after 52 weeks as measured by a Neuropsychological Test Battery (NTB) questionnaires and the Mini-mental State Examination (MMSE) questionnaire.
Query!
Timepoint [4]
287896
0
Baseline, 13, 26, 39 and 52 weeks after commencement of treatment with PBT2/placebo
Query!
Secondary outcome [5]
287897
0
To evaluate the effect of PBT2 compared to placebo 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!
Timepoint [5]
287897
0
Baseline and 52 weeks after commencement of treatment with PBT2/placebo
Query!
Eligibility
Key inclusion criteria
1. Prodromal Alzheimer's disease or mild Alzheimer's disease
2. 11C-PiB-PET positive (SUVR>1.7)
3. MMSE >or= 20
Query!
Minimum age
55
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Gender
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 other primary neurodegenerative disorders associated with dementia (e.g. Parkinson’s Disease Dementia, Fronto-temporal Lobe Dementia, Lewy Body Dementia or Vascular Dementia)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be entered on to the trial in sequence as their eligibility is confirmed. Participants will be allocated a unique Randomisation ID Number. Each participant will receive only PBT2 or placebo, with treatment assigned according to a Randomisation Schedule prepared by an independent statistician.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Randomisation Schedule is generated by an independent statistician at a ratio of 2:1 ie. 2/3 participants will receive 250mg PBT2 and 1/3 participants will receive matching placebo.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
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
17/10/2011
Query!
Actual
2/03/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
28/11/2012
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
42
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
498
0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Query!
Recruitment hospital [2]
499
0
Caulfield Hospital - Caulfield
Query!
Recruitment hospital [3]
500
0
Delmont Private Hospital - Glen Iris
Query!
Recruitment hospital [4]
501
0
Royal Melbourne Hospital - City campus - Parkville
Query!
Recruitment hospital [5]
502
0
Barwon Health - Geelong Hospital campus - Geelong
Query!
Recruitment postcode(s) [1]
4456
0
3081
Query!
Recruitment postcode(s) [2]
4457
0
3162
Query!
Recruitment postcode(s) [3]
5419
0
3146
Query!
Recruitment postcode(s) [4]
6242
0
3050 - Royal Melbourne Hospital
Query!
Recruitment postcode(s) [5]
6243
0
3220 - Geelong
Query!
Funding & Sponsors
Funding source category [1]
269806
0
Charities/Societies/Foundations
Query!
Name [1]
269806
0
Alzheimer's Drug Discovery Foundation (ADDF)
Query!
Address [1]
269806
0
57 West 57th Street,
Suite 904,
NEW YORK,
NY 10019 New York
Query!
Country [1]
269806
0
United States of America
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
Prana Biotechnology Limited
Query!
Address
Level 2, 369 Royal Parade
Parkville 3052
Victoria
Query!
Country
Australia
Query!
Secondary sponsor category [1]
268841
0
None
Query!
Name [1]
268841
0
Query!
Address [1]
268841
0
Query!
Country [1]
268841
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
271769
0
Austin Health Human Research Ethics Committee
Query!
Ethics committee address [1]
271769
0
Henry Buck Building
Austin Hospital
145 Studley Road
Heidelberg 3084
Victoria
Query!
Ethics committee country [1]
271769
0
Australia
Query!
Date submitted for ethics approval [1]
271769
0
17/08/2011
Query!
Approval date [1]
271769
0
17/11/2011
Query!
Ethics approval number [1]
271769
0
HREC/11/Austin/42
Query!
Summary
Brief summary
This is a Phase II clinical trial 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 objective is to compare the effect of PBT2 vs placebo 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 safety and tolerability, brain volume, brain metabolic activity, and cognition plus functional abilities will also be investigated.
Query!
Trial website
Query!
Trial related presentations / publications
1. Adlard PA, Cherny R, Finkelstein DI et al (2008). Rapid restoration of cognition in Alzheimer’s transgenic mice with 8-Hydroxy Quinoline analogs is associated with decreased interstitial Aß. Neuron 59: 43–55.
2. Adlard PA, Bica L, White AR et al (2011). Metal ionophore treatment restores dendritic spine density and synaptic protein levels in a mouse model of Alzheimer’s Disease. PLoS ONE 6: e17669. doi:10.1371/journal.pone.0017669.
3. Faux NG, Ritchie CW, Gunn A et al (2010). PBT2 rapidly improves cognition in Alzheimer's disease: additional Phase II analyses. J Alzheimers Dis 20: 509-16.
4. Ikonomovic MD, Klunk WE, Abrahamson EE et al (2008). Post-mortem correlates of in vivo PiB-PET amyloid imaging in a typical case of Alzheimer’s disease. Brain 131: 1630-45.
5. Klunk WE, Engler H, Nordberg A et al (2004). Imaging brain amyloid in Alzheimer’s disease with Pittsburgh compound-B. Ann Neurol 55: 306-19.
6. Lannfelt L, Blennow K, Zetterberg H et al (2008). Safety, efficacy and biomarker findings of PBT2 in targeting Aß as a modifying therapy for Alzheimer's disease: a Phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol 7:779-86. Erratum in: Lancet Neurol (2009) 8: 981.
7. Rowe CC, Ng S, Ackermann U et al (2007). Imaging ß-amyloid burden in aging and dementia. Neurology 68: 1718-25.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
33105
0
A/Prof Associate Professor Michael Woodward
Query!
Address
33105
0
Medical & Cognitive Research Unit
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg West, VIC 3081
Query!
Country
33105
0
Australia
Query!
Phone
33105
0
+61 (0)3 9496 2852
Query!
Fax
33105
0
Query!
Email
33105
0
michael.woodward@austin.org.au
Query!
Contact person for public queries
Name
16352
0
Ms Dianne Angus
Query!
Address
16352
0
Prana Biotechnology Limited
Level 2, 369 Royal Parade
Parkville 3052
Victoria
Query!
Country
16352
0
Australia
Query!
Phone
16352
0
+61 (0)3 9349 4906
Query!
Fax
16352
0
+61 (0)3 9348 0377
Query!
Email
16352
0
info@pranabio.com
Query!
Contact person for scientific queries
Name
7280
0
Ms Dianne Angus
Query!
Address
7280
0
Prana Biotechnology Limited
Level 2, 369 Royal Parade
Parkville 3052
Victoria
Query!
Country
7280
0
Australia
Query!
Phone
7280
0
+61 (0)3 9349 4906
Query!
Fax
7280
0
+61 (0)3 9348 0377
Query!
Email
7280
0
info@pranabio.com
Query!
Download to PDF