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TerminatedNCT00582855Updated Apr 19, 2016

Effect of AQW051 in Patients With Memory Impairment

A Phase 2 interventional study of AQW051 and Placebo in Mild Alzheimer's Disease and Amnestic Mild Cognitive Impairment, sponsored by Novartis Pharmaceuticals. Terminated at 12 sites in 3 countries. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-04-19.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mild Alzheimer's Disease
  • Amnestic Mild Cognitive Impairment

Keywords

  • AQW051
  • Mild Alzheimer's disease
  • Amnestic Mild Cognitive Impairment
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 54 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    1

    Drug: AQW051

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugAQW051
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Validated computerized cognitive assessment scores

    Time frame: 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

    Time frame: Throughout the study

07

Study locations

12 sites
  • Novartis Investigator Site
    Halifax, Canada
  • Novartis Investigator Site
    Montreal, Canada
  • Novartis Investigator Site
    Toronto, Canada
  • Novartis Investigator Site
    Bloemfontein, South Africa
  • Novartis Investigator Site
    George, South Africa
  • Novartis Investigator Site
    Port Elizabeth, South Africa
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00582855
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 28, 2007
Start date
Dec 2007
Primary completion
Feb 2009
Last update
Apr 19, 2016

Study contacts

Novartis Pharmaceuticals
principal investigator · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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