Effect of AQW051 in Patients With Memory Impairment
This study has been terminated.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00582855
First received: December 21, 2007
Last updated: February 3, 2011
Last verified: February 2011
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Validated computerized cognitive assessment scores [ Time Frame: Througout the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Validated computerized cognitive assessment scores, the different scores from the Alzheimer's Disease Assessment Score-cognitive subscale (ADAS-Cog), Quality of Life-Alzheimer disease scale and the Disability Assessment for Dementia scale [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
| Enrollment: | 54 |
| Study Start Date: | December 2007 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: AQW051 |
| Placebo Comparator: 2 | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 55 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Willing and able to give written informed consent
- Meet the diagnostic criteria for either amnestic mild cognitive impairment (amnestic MCI) or mild Alzheimer's Disease (AD).
- Structural brain scan within the last 6 months prior to randomization that indicates no other underlying disease, in particular no evidence for vascular pathology except for normal age-related white matter/incidental white matter changes which is normal for this age group.
- Daily contact with a primary caregiver/partner
Exclusion Criteria:
- Immune therapy targeting Alzheimer beta amyloid within the last 12 months
- Institutionalized
- Disability that may prevent completion of all study requirements (e.g., blindness, deafness, or communication difficulty)
- Reported use of tobacco products in the previous 3 months or have a urine cotinine level greater than 500 ng/ml
- Past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history (grandparents, parents, and siblings) of prolonged QT-interval syndrome
- History or current diagnosis of conditions specified in the protocol.
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582855
Locations
| Canada | |
| Novartis Investigator Site | |
| Halifax, Canada | |
| Novartis Investigator Site | |
| Montreal, Canada | |
| Novartis Investigator Site | |
| Toronto, Canada | |
| South Africa | |
| Novartis Investigator Site | |
| Bloemfontein, South Africa | |
| Novartis Investigator Site | |
| George, South Africa | |
| Novartis Investigator Site | |
| Port Elizabeth, South Africa | |
| United Kingdom | |
| Novartis Investigator Site | |
| Blackpool, United Kingdom | |
| Novartis Investigator Site | |
| Epping, United Kingdom | |
| Novartis Investigator Site | |
| Glasgow, United Kingdom | |
| Novartis Investigator Site | |
| Manchester, United Kingdom | |
| Novartis Investigator Site | |
| Southampton, United Kingdom | |
| Novartis Investigator Site | |
| Swindon, United Kingdom | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00582855 History of Changes |
| Other Study ID Numbers: | CAQW051A2104 |
| Study First Received: | December 21, 2007 |
| Last Updated: | February 3, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
AQW051 Mild Alzheimer's disease Amnestic Mild Cognitive Impairment |
Additional relevant MeSH terms:
|
Alzheimer Disease Cognition Disorders Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013