TerminatedPhase 2

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)

Lead sponsor

Novartis Pharmaceuticals

Asset

AQW051

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Validated computerized cognitive assessment scores

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCAQW051A2104

NCT IDNCT00582855

Timeline

Milestones

Study start2007-12 (month precision)

Study first posted2007-12-28estimated

Primary completion2009-02actual (month precision)

Last update posted2016-04-19estimated

Assets

Drug assets

AQW051

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

2 endpoints

Primary/protocol endpoint

Validated computerized cognitive assessment scores

Time frame:Througout the study

descriptive

Secondary/protocol endpoint

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

ADAS-Cog

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.