Effect of AQW051 in Patients With Memory Impairment

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00582855
First received: December 21, 2007
Last updated: February 3, 2011
Last verified: February 2011
  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
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, see Learn About Clinical Studies.

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
Mild Cognitive Impairment
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 September 18, 2014