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

NCT ID: NCT00471211

Last Updated: 2008-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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PBT2

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prana Biotechnology Limited

INDUSTRY

Sponsor Role lead

Principal Investigators

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Lars Lannfelt, Professor

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital, Sweden

Locations

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Sydney, New South Wales, Australia

Site Status

Sydney, New South Wales, Australia

Site Status

Adelaide, South Australia, Australia

Site Status

Melbourne, Victoria, Australia

Site Status

Melbourne, Victoria, Australia

Site Status

Melbourne, Victoria, Australia

Site Status

Melbourne, Victoria, Australia

Site Status

Falköping, , Sweden

Site Status

Kalix, , Sweden

Site Status

Kalmar, , Sweden

Site Status

Lund, , Sweden

Site Status

Malmo, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Umeå, , Sweden

Site Status

Uppsala, , Sweden

Site Status

Countries

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Australia Sweden

References

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Lannfelt L, Blennow K, Zetterberg H, Batsman S, Ames D, Harrison J, Masters CL, Targum S, Bush AI, Murdoch R, Wilson J, Ritchie CW; PBT2-201-EURO study group. Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer's disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2008 Sep;7(9):779-86. doi: 10.1016/S1474-4422(08)70167-4. Epub 2008 Jul 30.

Reference Type DERIVED
PMID: 18672400 (View on PubMed)

Other Identifiers

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PBT2-201

Identifier Type: -

Identifier Source: org_study_id

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