PIA-Study
ACTRN12621000726853
Treatment
Phase 2
Government body,National Health Medicine Research Council
Prof John Mamo
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 .... Read more
18 years of age or older, A positive amyloid biomarker (PET scan) indicative of AD pathology, Mini-mental-state examination (MMSE) score of 20 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 .... Read more
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 .... Read more
No
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 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 .... Read more
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 .... Read more
Outcome: To evaluate the preliminary efficacy of 2x daily 250 mg Lorelco™ on cognitive performance in Alzheimer’s patients over a 102 week treatment periodTimepoint: 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