Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00471211 |
Recruitment Status :
Completed
First Posted : May 9, 2007
Last Update Posted : January 16, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: PBT2 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 Start Date : | December 2006 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

- Safety [ Time Frame: Study duration ]
- Change from baseline in biomarkers; Change from baseline in cognitive and global function scales [ Time Frame: Study duration ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 56 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471211
Australia, New South Wales | |
Sydney, New South Wales, Australia, 2031 | |
Sydney, New South Wales, Australia, 2077 | |
Australia, South Australia | |
Adelaide, South Australia, Australia, 5011 | |
Australia, Victoria | |
Melbourne, Victoria, Australia, 3081 | |
Melbourne, Victoria, Australia, 3101 | |
Melbourne, Victoria, Australia, 3146 | |
Melbourne, Victoria, Australia, 3199 | |
Sweden | |
Falkoping, Sweden, 521 85 | |
Kalix, Sweden, 952 81 | |
Kalmar, Sweden, 391 85 | |
Lund, Sweden, 85 | |
Malmo, Sweden, 205 20 | |
Stockholm, Sweden, 112 98 | |
Umea, Sweden, 901 85 | |
Uppsala, Sweden, 751 85 |
Principal Investigator: | Lars Lannfelt, Professor | Uppsala University Hospital, Sweden |
ClinicalTrials.gov Identifier: | NCT00471211 |
Other Study ID Numbers: |
PBT2-201 |
First Posted: | May 9, 2007 Key Record Dates |
Last Update Posted: | January 16, 2008 |
Last Verified: | January 2008 |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |