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

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

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

U.S. FDA Resources

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)

Further study details as provided by Novartis:

Primary Outcome Measures:

Validated computerized cognitive assessment scores [ Time Frame: throughout the study ]

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 ]

Estimated Enrollment:	126
Study Start Date:	December 2007
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AQW051
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	60 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
Aged 60 - 85 years

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

Contacts


Contact: Novartis	+41 61 324 1111

Locations


Canada
	Novartis Investigator Site	Recruiting
	Montreal, Canada
	Contact: NOVARTIS 862 778 8300
	Novartis Investigator Site	Recruiting
	Toronto, Canada
	Contact: NOVARTIS 862 778 8300
	Novartis Investigator Site	Recruiting
	Halifax, Canada
	Contact: NOVARTIS 862 778 8300

United Kingdom
	Novartis Investigator Site	Recruiting
	Manchester, United Kingdom
	Contact: Novartis +41 61 324 1111
	Novartis Investigator Site	Recruiting
	Epping, United Kingdom
	Contact: NOVARTIS +41 61 324 1111
	Novartis Investigator Site	Recruiting
	Swindon, United Kingdom
	Contact: Novartis +41 61 324 1111
	Novartis Investigator Site	Recruiting
	Blackpool, United Kingdom
	Contact: Novartis +41 61 324 1111
	Novartis Investigator Site	Recruiting
	Glasgow, United Kingdom
	Contact: NOVARTIS +41 61 324 1111
	Novartis Investigator Site	Recruiting
	Southampton, United Kingdom
	Contact: NOVARTIS +41 61 324 1111

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Novartis	Novartis investigative site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CAQW051A2104
First Received:	December 21, 2007
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00582855
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada

Keywords provided by Novartis:

AQW051, Mild Alzheimer's disease, amnestic Mild Cognitive Impairment

Study placed in the following topic categories:

Signs and Symptoms

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Alzheimer Disease

Central Nervous System Diseases

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Nervous System Diseases

Tauopathies

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00582855