Effect of AQW051 in Patients With Memory Impairment

NCT00582855 | Terminated Phase 2

• 1 other identifier: CAQW051A2104
• Study Type: interventional
• Target: 54
• Locations: 3 countries
• Sites: 12

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.

Conditions

Mild Alzheimer's Disease; Amnestic Mild Cognitive Impairment

Keywords

AQW051; Mild Alzheimer's disease; Amnestic Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Validated computerized cognitive assessment scores

  Througout the study

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: AQW051

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AQW051 DRUG

1

Placebo DRUG

2

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (12)

Novartis Investigator Site

Halifax, Canada

Location

Novartis Investigator Site

Montreal, Canada

Location

Novartis Investigator Site

Toronto, Canada

Location

Novartis Investigator Site

Bloemfontein, South Africa

Location

Novartis Investigator Site

George, South Africa

Location

Novartis Investigator Site

Port Elizabeth, South Africa

Location

Novartis Investigator Site

Blackpool, United Kingdom

Location

Novartis Investigator Site

Epping, United Kingdom

Location

Novartis Investigator Site

Glasgow, United Kingdom

Location

Novartis Investigator Site

Manchester, United Kingdom

Location

Novartis Investigator Site

Southampton, United Kingdom

Location

Novartis Investigator Site

Swindon, United Kingdom

Location

MeSH Terms

Interventions

3-(6-p-tolylpyridin-3-yloxy)-1-azabicyclo(2.2.2)octane

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: December 1, 2007
• Primary Completion: February 1, 2009
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

ZA (3); GB (6); CA (3)