Effect of AQW051 in Patients With Memory Impairment - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00582855

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 II

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Mild Cognitive Impairment

U.S. FDA Resources

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

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 February 12, 2012