Clinical trial NCT00582855: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mild Alzheimer's Disease
Amnestic Mild Cognitive Impairment
Keywords: AQW051
Mild Alzheimer's disease
Amnestic Mild Cognitive Impairment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-28
Enrollment: 54
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Validated computerized cognitive assessment scores
timeFrame: Througout the study
Secondary outcomes:
measure: 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
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Novartis Investigator Site
city: Montreal
country: Canada
facility: Novartis Investigator Site
city: Toronto
country: Canada
facility: Novartis Investigator Site
city: Bloemfontein
country: South Africa
facility: Novartis Investigator Site
city: George
country: South Africa
facility: Novartis Investigator Site
city: Port Elizabeth
country: South Africa
facility: Novartis Investigator Site
city: Blackpool
country: United Kingdom
facility: Novartis Investigator Site
city: Epping
country: United Kingdom
facility: Novartis Investigator Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigator Site
city: Manchester
country: United Kingdom
facility: Novartis Investigator Site
city: Southampton
country: United Kingdom
facility: Novartis Investigator Site
city: Swindon
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References: