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

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PBT2

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

56 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Change from baseline in biomarkers; Change from baseline in cognitive and global function scales

Full Information

NCT ID

NCT00471211

First Posted

May 8, 2007

Last Updated

January 13, 2008

Sponsor

Prana Biotechnology Limited

1. Study Identification

Unique Protocol Identification Number

NCT00471211

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Prana Biotechnology Limited

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

PBT2

Primary Outcome Measure Information:

Title

Safety

Time Frame

Study duration

Secondary Outcome Measure Information:

Title

Change from baseline in biomarkers; Change from baseline in cognitive and global function scales

Time Frame

Study duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

56 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars Lannfelt, Professor

Organizational Affiliation

Uppsala University Hospital, Sweden

Official's Role

Principal Investigator

Facility Information:

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2077

Country

Australia

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3101

Country

Australia

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3146

Country

Australia

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

City

Falkoping

ZIP/Postal Code

521 85

Country

Sweden

City

Kalix

ZIP/Postal Code

952 81

Country

Sweden

City

Kalmar

ZIP/Postal Code

391 85

Country

Sweden

City

Lund

ZIP/Postal Code

Country

Sweden

City

Malmo

ZIP/Postal Code

205 20

Country

Sweden

City

Stockholm

ZIP/Postal Code

112 98

Country

Sweden

City

Umea

ZIP/Postal Code

901 85

Country

Sweden

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

18672400

Citation

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. Erratum In: Lancet Neurol. 2009 Nov;8(11):981.

Results Reference

derived

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

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