Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease

Prana Biotechnology

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: PBT2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00471211

PBT2-201

Details and patient eligibility

About

The purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of PBT2 administered for 12 weeks compared to placebo in patients with early Alzheimer's disease treated with an acetylcholinesterase inhibitor.

Enrollment: 80 estimated patients

Sex: All

Ages: 56+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of probable early Alzheimer's disease
• stable dose of acetylcholinesterase inhibitor
• community dwelling
• stable medical condition

Exclusion criteria

• unstable and significant medical conditions
• recurrent major psychiatric disorder
• treatment with memantine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind