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Effect of AQW051 in Patients With Memory Impairment

Primary Purpose

Mild Alzheimer's Disease, Amnestic Mild Cognitive Impairment

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AQW051
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Alzheimer's Disease focused on measuring AQW051, Mild Alzheimer's disease, Amnestic Mild Cognitive Impairment

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Validated computerized cognitive assessment scores

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

Full Information

First Posted
December 21, 2007
Last Updated
April 15, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00582855
Brief Title
Effect of AQW051 in Patients With Memory Impairment
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Alzheimer's Disease, Amnestic Mild Cognitive Impairment
Keywords
AQW051, Mild Alzheimer's disease, Amnestic Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AQW051
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Validated computerized cognitive assessment scores
Time Frame
Througout the study
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigator Site
City
Halifax
Country
Canada
Facility Name
Novartis Investigator Site
City
Montreal
Country
Canada
Facility Name
Novartis Investigator Site
City
Toronto
Country
Canada
Facility Name
Novartis Investigator Site
City
Bloemfontein
Country
South Africa
Facility Name
Novartis Investigator Site
City
George
Country
South Africa
Facility Name
Novartis Investigator Site
City
Port Elizabeth
Country
South Africa
Facility Name
Novartis Investigator Site
City
Blackpool
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Epping
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Glasgow
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Manchester
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Southampton
Country
United Kingdom
Facility Name
Novartis Investigator Site
City
Swindon
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Effect of AQW051 in Patients With Memory Impairment

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