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CompletedPhase 1

A Clinical Study to Assess Single and Repeat Doses of a New Medication (GSK933776) in Patients With Alzheimer's Disease

A Randomised, Single-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Intravenous Infusion of GSK933776 in Patients With Alzheimer's Disease.

Lead sponsor

GlaxoSmithKline

Asset

GSK933776

Listed sites

7

Recruiting sites

-

Enrollment

50

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 18-26•Study partner/caregiver required•MRI contraindications excluded•Brain MRI excludes >3 microhemorrhages

Primary endpoint

•Adverse events. Changes suggesting potential adverse events detected in

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 ID106006
NCT IDNCT00459550

Timeline

Milestones

Study start2007-03-12actual
Study first posted2007-04-12estimated
Primary completion2011-05-30actual
Study completion2011-05-30actual
Last update posted2017-07-21actual

Assets

Drug assets

GSK933776

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female subject with a clinical diagnosis of probable Alzheimer's disease
•Subject has mild AD with Mini Mental State Examination (MMSE) score 18-26 inclusive at the screening visit.
•Age between 55 and 80 years.
•Female subjects must be post-menopausal or surgically sterile.
•Male subjects whose partner is of child-bearing potential or have been menopausal for <2 years must use an adequate form of contraception.
•Subject has the ability to comply with procedures for cognitive and other testing \& is fluent in the language used for the administration of the cognitive tests.
•Subject lives with (or has substantial periods of contact with) a permanent caregiver who is willing to oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status.
•Subject has provided full written informed consent prior to the performance of any protocol-specified procedure.
•Caregiver has provided a full written informed consent on his/her own behalf prior to the performance of any protocol-specified procedure

Exclusion criteria

•History and/or evidence of any other central nervous system (CNS) disorder that could be interpreted as a cause of dementia.
•Subjects currently living in a nursing home.
•Subjects who are unable to provide informed consent due to cognitive status
•Screening brain MRI with 1 or more of the following conditions: not consistent with AD, evidence of other CNS conditions, shows more than minimal vascular changes, more than 3 microhaemorrhage lesions.
•Focal findings on the neurological exam.
•Any contraindication to lumbar puncture.
•History or evidence of significant psychiatric illness such as schizophrenia or bipolar affective disorder or significant neurological disease other than AD.
•TIA/stroke in the last 3 years, type 1 or type 2 diabetes mellitus, active cardiovascular disease, or other uncontrolled risk factors for stroke.
•Current or recent drug or alcohol abuse or dependence or recent or remote history of the same if that could be a contributing factor to the dementia.
•History or evidence of any significant autoimmune disease or disorder.
•History of seizures (excluding febrile seizures in childhood), current blood clotting or bleeding disorder or conditions that predispose to these (e.g. cancer), current clinically significant systemic illness or significant infection within 30 days that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study.
•History of cerebral amyloid antiopathy and/or hypertensive cerebral haemorrhage or with a known risk of intercerebral haemorrhage/microhaemorrhage.
•Treatment which cholinesterase inhibitors, memantine or selegiline unless the therapy was instituted at least 3 months prior to the administration of GSK933776, at a stable dosage in the 2 months prior and the same regimen will be continued for the duration of the trial and the subject is free from any clinically significant side effects attributable to the drug.
•Subjects who have discontinued cholinesterase inhibitors, memantine, cognitive enhancing agents, or drugs that potentially affect cognition in the 60 days prior to screening.
•Unless maintained on a stable dose regimen for at least 30 days prior to screening, any other medications with the potential to affect cognition.
•Use of drugs with platelet anti-aggregant or anti-coagulant properties (excluding the use of aspirin 325 mg/day or less), anticonvulsants for seizures or narcotic medication.
•History of or current chronic use of systemic steroids or other immunosuppressants.
•Prior participation in clinical investigations involving therapeutic monoclonal antibodies or proteins derived from monoclonal antibodies or any investigations of treatments or use of experimental medications for AD or any other investigational medication or device within 60 days prior to screening or within 5 half-lives of use of such a medication prior to screening, whichever is longer.
•Contraindications for MRI: pacemaker, aneurysm clips, artificial heart valves, other metal foreign body, claustrophobia, etc.
•Smoking more than 20 cigarettes or equivalent per day.

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

Neuroimaging
1
Fluid / digital biomarkers
1

Neuroimaging

1 endpoint
Primary/protocol endpoint

Adverse events. Changes suggesting potential adverse events detected in the physical & neurological examination, brain MRI, cognitive status, laboratory parameters, ECG & vital signs.

Time frame:12 weeks for Part A; 34 weeks in Part B

event count, event

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

Plasma pharmacokinetic parameters of GSK933776. Pharmacodynamic effects of GSK 933776. CSF detectable levels of GSK933776. Effects of GSK933776 on plasma and CSF biomarkers. Titre & neutralising activity of anti-GSK933776 antibodies. Exploratory PET scan

Time frame:12 weeks for Part A; 34 weeks in Part B

descriptive

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.