CompletedPhase 2

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

Lead sponsor

Prana Biotechnology Limited

Asset

PBT2

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•AD symptomatic therapy: stable

Primary endpoint

•Safety

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00471211

Org study IDPBT2-201

Timeline

Milestones

Study start2006-12 (month precision)

Study first posted2007-05-09estimated

Primary completion2007-12actual (month precision)

Study completion2007-12actual (month precision)

Last update posted2008-01-16estimated

Assets

Drug assets

PBT2

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age56 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety

Time frame:Study duration

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

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

Time frame:Study duration

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID18672400via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.