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

A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Three-Group Study to Assess the Safety, Tolerability and Efficacy of Two Dose Levels of PBT2 to Slow Progression of Disease in Patients With Early Alzheimer's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00471211

Enrollment

Registered

2007-05-09

Start date

2006-12-31

Completion date

2007-12-31

Last updated

2008-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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.

Interventions

DRUGPBT2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

56 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Safety	Study duration

Secondary

Measure	Time frame
Change from baseline in biomarkers; Change from baseline in cognitive and global function scales	Study duration

Countries

Australia, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026