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.
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.
Alterity Therapeutics
40 participants
Jul 24, 2013
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- Patients who have completed Visit 10 (Week 52) of the PBT2-204 (IMAGINE) clinical trial [ACTRN12611001008910].
Exclusion Criteria2
- Allergy to PBT2 or its excipients (microcrystalline cellulose, pregelatinised starch, colloidal silicon dioxide, povidone K29/32 and sodium stearyl fumurate).
- Have developed any clinically significant uncontrolled medical, ocular or psychiatric illness during PBT2-204.
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Interventions
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.
Locations(3)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12613000777796