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.
Phase 2
Completed
- Conditions
- Prodromal Alzheimer's disease or mild Alzheimer's diseaseMental Health - Other mental health disordersNeurological - Alzheimer's disease
- Registration Number
- ACTRN12613000777796
- Lead Sponsor
- Alterity Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
1. Patients who have completed Visit 10 (Week 52) of the PBT2-204 (IMAGINE) clinical trial [ACTRN12611001008910].
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 developed any clinically significant uncontrolled medical, ocular or psychiatric illness during PBT2-204.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method