Effect of AQW051 in Patients With Memory Impairment

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. Identifier: NCT00582855
Recruitment Status : Terminated
First Posted : December 28, 2007
Last Update Posted : April 19, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

December 21, 2007
December 28, 2007
April 19, 2016
December 2007
February 2009   (Final data collection date for primary outcome measure)
Validated computerized cognitive assessment scores [ Time Frame: Througout the study ]
Validated computerized cognitive assessment scores [ Time Frame: throughout the study ]
Complete list of historical versions of study NCT00582855 on Archive Site
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 ]
Same as current
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Effect of AQW051 in Patients With Memory Impairment
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)
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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Mild Alzheimer's Disease
  • Amnestic Mild Cognitive Impairment
  • Drug: AQW051
  • Drug: Placebo
  • Experimental: 1
    Intervention: Drug: AQW051
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
February 2009   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
55 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   South Africa,   United Kingdom
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
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Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP