Effect of AQW051 in Patients With Memory Impairment

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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00582855

Enrollment

Registered

2007-12-28

Start date

2007-12-31

Completion date

Unknown

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amnestic Mild Cognitive Impairment, Mild Alzheimer's Disease

Keywords

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

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.

Interventions

DRUGAQW051

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

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/

Design outcomes

Primary

Measure	Time frame
Validated computerized cognitive assessment scores	Througout the study

Secondary

Measure	Time frame
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

Countries

Canada, South Africa, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026