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.
Phase 2
Completed
- Conditions
- Prodromal Alzheimer's disease or mild Alzheimer's diseaseMental Health - Other mental health disordersNeurological - Dementias
- Registration Number
- ACTRN12611001008910
- Lead Sponsor
- Alterity Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
1. Prodromal Alzheimer's disease or mild Alzheimer's disease
2. 11C-PiB-PET positive (SUVR>1.7)
3. MMSE >or= 20
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[Baseline, 26 and 52 weeks after commencement of treatment with PBT2/placebo]
- Secondary Outcome Measures
Name Time Method