Effect of AQW051 in Patients With Memory Impairment

Amnestic Mild Cognitive Impairment Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00582855
• Other study ID #: CAQW051A2104
• Status: Terminated
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: April 15, 2016
• Start date: December 2007

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Amnestic Mild Cognitive Impairment
• Cognition Disorders
• Mild Alzheimer's Disease
• Mild Cognitive Impairment

Intervention

Drug:
• AQW051

• Placebo

Locations

Country	Name	City	State
Canada	Novartis Investigator Site	Halifax
Canada	Novartis Investigator Site	Montreal
Canada	Novartis Investigator Site	Toronto
South Africa	Novartis Investigator Site	Bloemfontein
South Africa	Novartis Investigator Site	George
South Africa	Novartis Investigator Site	Port Elizabeth
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Canada,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validated computerized cognitive assessment scores		Througout the study	No
Secondary	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		Throughout the study	No