CompletedPhase 2

A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease

A Phase IIa/b Double-blind, Randomised, Placebo-controlled, Linear Trend Design Dose-ranging Study to Investigate the Effects of 24 Weeks of Monotherapy With SB-742457 on Cognition in Subjects With Mild to Moderate Alzheimer's Disease

Lead sponsor

GlaxoSmithKline

Asset

Intepirdine

Listed sites

Recruiting sites

Enrollment

380

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 12-24

Primary endpoint

•Cognition and function after 24 weeks

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 IDAZ3100603

NCT IDNCT00224497

Timeline

Milestones

Study start2005-09 (month precision)

Study first posted2005-09-23estimated

Last update posted2009-12-24estimated

Assets

Drug assets

Intepirdine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of probable mild-to-moderate Alzheimer's disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24.

•Subjects and their caregivers must provide informed consent prior to study entry.

•Adequate blood pressure and laboratory values

Exclusion criteria

•Females of child-bearing potential.

•Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.

•Subjects taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes.

•Subjects taking agents for which there is a theoretical risk of interaction with SB-742457.

•Subjects with known hypersensitivity to sunlight or seizures.

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.

Coverage by outcome category

Function / daily living

Other (unclassified)

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change in behavioural symptoms, activities of daily living and caregiver burden after 24 weeks. Changes in all symptoms at 8 and 12 weeks. Safety and tolerability. PK and dose response profiling. Efficacy related to ApoE status.

change from baseline, improvement

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Change in cognition and function after 24 weeks.

change from baseline, improvement

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.