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CompletedPhase 2

SB-742457 And Donepezil In Alzheimer's Disease

A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects With Mild to Moderate Alzheimer's Disease

Lead sponsor

GlaxoSmithKline

Assets

Donepezil / Intepirdine

Listed sites

26

Recruiting sites

-

Enrollment

200

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 IDAZ3106242
NCT IDNCT00348192

Timeline

Milestones

Study start2006-05 (month precision)
Study first posted2006-07-04estimated
Last update posted2009-06-02estimated

Assets

Drug assets

DonepezilIntepirdine

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 Alzheimers 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 or donepezil.
•Subjects with conditions which might be exacerbated by exposure to donepezil.
•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
1
Other (unclassified)
1

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change in behavioral symptoms, activities of daily living and caregiver burden after 24 weeks Changes in all symptoms at 8 and 12 weeks Safety and tolerability PK (pharmacokinetic) profiling. Efficacy related to ApoE and HTR6 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

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.