Data

Probucol in Alzheimer's Study 2020 (PIA 2020)

Curtin University

Dataset description

The aim of this study is to understand whether or not treatment with Probucol supports cognitive function in participants with MCI/mild-dementia due to AD. The trial is specifically designed to provide evidence that treatment with Probucol may slow the decline of cognitive ability and functional state. The presence of cognitive impairment will be assessed using neuro-cognitive assessments. Participants will be randomly assigned to one of two groups, group 1 (placebo) or group 2 (treatment). This is a double-blind trial meaning the participant and study doctor will not be aware which group the participant has been randomised to. The study will be 104 weeks in duration (2 years). Participants will be required to take one tablet a day (with food) for the first three weeks, and then two tablets a day (morning and night, with food) for the remainder of the trial. During the screening/pre-baseline phase participants will be asked about their medical history, complete a physical and neurological examination, an Electrocardiogram (ECG), and a blood test. Participants will also complete Neuro-cognitive assessments (memory and thinking tasks), as well as a Magnetic Resonance Imaging (MRI) scan and/or a Positron emission tomography (PET) scan. During the treatment phase, participants will be required to visit the study doctor on 10 separate occasions (once a week for the first 3 weeks, and then at approximately 3 monthly intervals). Each visit will involve a health and safety assessment. Neuro-cognitive assessments will also be conducted at week 26 (6 months), 52 (12 months), and 78 (18 months). A blood sample will also be taken at each visit. At completion of the treatment phase (week 104), participants will recomplete the Neuro-cognitive assessments, MRI and/or PET scan, and provide a final blood sample. During the course of the trial, participants will be required to nominate a 'study partner' (spouse/partner/carer). The study partner will need to attend at least one screening visit. In addition, study partners should make themselves available by phone or preferably in person, to provide information to the study as required. Participants will need to identify a study partner to be eligible to take part in this study.
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Source Study

Trial acronym

PIA-Study

Trial ID

ACTRN12621000726853

Purpose

Treatment

Phase

Phase 2

Funding

Government body,National Health Medicine Research Council

Scientific enquiries

Prof John Mamo

Brief Summary

The aim of this study is to understand whether or not treatment with Probucol supports cognitive function in participants with MCI/mild-dementia due to AD. The trial is specifically designed to provide evidence that treatment with Probucol may slow the decline of cognitive ability and functional state. The presence of cognitive impairment will be assessed using neuro-cognitive assessments. Participants will be randomly assigned to one of two groups, group 1 (placebo) or group 2 (treatment). This ....
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Key Inclusion Criteria

18 years of age or older, A positive amyloid biomarker (PET scan) indicative of AD pathology, Mini-mental-state examination (MMSE) score of 22 or greater, Free and cued selective reminding test (FCSRT) cueing index score of less than or equal to 0.79, OR a free recall of less than or equal to 17. Clinical Dementia Rating (CDR) global score of 0.5 or 1.0. A study partner (partner/spouse/carer) consents to the minimum requirements: Study partner will attend at least one screening visit Study partn ....
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Key Exclusion Criteria

A patient who meets any of the following exclusion criteria will not be eligible for inclusion in the study: 1. Recorded number of falls in previous 12 months and during trial. Participants who report multiple falls with potential loss of consciousness will be excluded 2. History of QTc-induced prolongation and willingness to limit use of over-the- counter, or prescription medicines (e.g. anti-histamines) known to prolong QTc interval. Corrected QT interval using Bazett's formula (QTcB) interval ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    314

Min. age    18 Years

Max. age    85 Years

Sex    Both males and females

Condition category    Alzheimer's disease

Condition code    Neurological

Intervention

Intervention code Treatment: Drugs

The PIA-Study is a randomised controlled research trial examining whether intervention with Probucol supports cognitive function in AD. Participants are randomly assigned to one of two groups, group 1 (placebo) or group 2 (treatment). After consenting to participate in the study, screening procedures will occur between Days -56 and -1. All subjects must have measurable mild or moderate Alzheimer’s disease, and accordingly screening procedures will include: • A positive amyloid biomarker (PET sca ....
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Comparison

Control group Placebo

Placebo composition: opaque capsules with no active ingredients and a filler of microcrystalline cellulose. Study medication will commence (day 1, week 1) with a single dose escalation design with all participants receiving initially for two-weeks 1 X placebo per day. Unused tablets are to be returned to monitor drug compliance. Arm 2 (placebo) Subjects will be dosed as: • Week 3: 1 x matching placebo taken in the morning, with food. • Week 4 – 104: 1 x matching placebo taken in the morning, wit ....
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Outcomes

Outcome: To evaluate the preliminary efficacy of 2x daily 250 mg Lorelco™ on cognitive performance in Alzheimer’s patients over a 102 week treatment period
Timepoint: The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) will be completed at baseline (week 3, day 1), Week 26 (6 months), week 52 (1 year), week 78 (18 months), and week 104 (2 years; primary endpoint) from randomisation

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au