Probucol in Alzheimer's Study 2020 (PIA 2020)
- Conditions
- Alzheimer's diseaseNeurological - Alzheimer's disease
- Registration Number
- ACTRN12621000726853
- Lead Sponsor
- Curtin University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 314
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 partner will be available via phone or in person to provide information to the study as required
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 > 490 msec for males, or 500 msec for females, as detected by ECG and confirmed by physician. Participants who have a history of QTc-induced prolongation and are unwilling to limit use of medication will be excluded.
3. Evidence of abnormal cardiac function as defined by any of the following:
a. Myocardial infarction within 6 months of Cycle 1, Day 1
b. Symptomatic congestive heart failure (New York Heart Association > Class II)
c. Unstable angina
d. Unstable atrial fibrillation including paroxysmal atrial fibrillation. Medicated, stable atrial fibrillation will be assessed by the study doctor on a case-by-case basis.
e. Frequent multifocal ventricular arrhythmia
4. Unable to swallow oral medications.
5. Gastrointestinal conditions that, in the opinion of the Investigator, could affect the absorption of study drug.
6. Use of any prescription or non-prescription (including herbal) medications, or consumption of foods known to be strong QT prolongation within 7 days prior to the first administration of Lorelco™ and for the duration of the study . These include (but are not limited to):
a. Medications
b. With significant central anticholinergic effects,
c. Sedatives,
d. Antiparkinsonian medications that cannot be stopped prior to study entry,
e. Any investigational treatment for AD
7. ‘Current diagnosis of cancer (within 3 years) and/or undergoing chemotherapy, with exception to cancers of the skin such as basal or squamous cell carcinoma in situ of the skin.
8. Significant head injury within 5 years
9. Electrolyte imbalance (e.g. on high steroids, pituitary tumours, and Addison disease)
10. Hypokalaemia, hypomagnesaemia and hypocalcaemia
11. They have other neurologic or psychiatric diagnosis that in the opinion of the investigator could interfere with cognitive function,
12. Major surgery is planned during the conduct of the trial, or a clinical event has occurred in the six months preceding study inclusion that may compromise ability to participate for the duration of the study,
13. Evidence of stroke where the clinical effects are clearly temporally related to the onset of cognitive impairment.
14. Current diagnosis with a psychiatric disorder, or taking psychotropic medications,
15. Other excluded medications will be those that are;
• Specifically contraindicated with Probucol, based on historic clinical indications for the treatment of cardiovascular disease. Stable use (for at least 3 months) of cholinesterase inhibitors and memantine will be allowed.
• Patients on high dose loop-diuretics or thiazide diuretic medications, will be excluded if taking maximum dose of furosemide or Bendroflumethiazide
16. Self-reported human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBsAg) or hepatitis C virus (HCV).
17. Any inflammatory or chronic pain condition that necessitates regular use of opiates/opioids,
18. Major surgery within 28 days of Cycle 1, Day 1, or minor surgical procedures within 7 days of Cycle 1, Da
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the preliminary efficacy of 2x daily 250 mg Lorelco™ on cognitive performance in Alzheimer’s patients over a 102 week treatment period[ 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]
- Secondary Outcome Measures
Name Time Method