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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00582855 |
This study will investigate AQW051 in patients with either mild Alzheimer's disease or amnestic mild cognitive impairment. The effect on cognitive impairment will be measure using validated computerized tests which measure cognitive function. This study will also explore the safety and tolerability of AQW051 in these patients.
Condition | Intervention | Phase |
---|---|---|
Mild Alzheimer's Disease Amnestic Mild Cognitive Impairment |
Drug: AQW051 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 4-Week, Parallel-Group, Randomized, Double-Blind, Placebo-Controlled, Adaptive Proof of Concept Study of AQW051 at up to Three Dose Levels for the Treatment of Patients With Findings Consistent With Mild Alzheimer's Disease (AD) or Amnestic Mild Cognitive Impairment (Amnestic MCI) |
Enrollment: | 54 |
Study Start Date: | December 2007 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: AQW051 |
2: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 55 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Canada | |
Novartis Investigator Site | |
Montreal, Canada | |
Novartis Investigator Site | |
Toronto, Canada | |
Novartis Investigator Site | |
Halifax, Canada | |
South Africa | |
Novartis Investigator Site | |
Port Elizabeth, South Africa | |
Novartis Investigator Site | |
George, South Africa | |
Novartis Investigator Site | |
Bloemfontein, South Africa | |
United Kingdom | |
Novartis Investigator Site | |
Epping, United Kingdom | |
Novartis Investigator Site | |
Southampton, United Kingdom | |
Novartis Investigator Site | |
Swindon, United Kingdom | |
Novartis Investigator Site | |
Glasgow, United Kingdom | |
Novartis Investigator Site | |
Blackpool, United Kingdom | |
Novartis Investigator Site | |
Manchester, United Kingdom |
Principal Investigator: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CAQW051A2104 |
Study First Received: | December 21, 2007 |
Last Updated: | June 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00582855 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
AQW051 Mild Alzheimer's disease Amnestic Mild Cognitive Impairment |
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia Cognition Disorders |