CompletedPhase 1

Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient

Modulation of Beta-amyloid Levels in CSF and Plasma by GSK933776 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment

Lead sponsor

GlaxoSmithKline

Asset

GSK933776

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MMSE 20-26•AD symptomatic therapy: stable•MRI contraindications excluded

Primary endpoint

•Temporal changes of amyloid beta levels in CSF after GSK933776 single dose

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 ID113043

NCT IDNCT01424436

Timeline

Milestones

Study start2010-05-19actual

Study first posted2011-08-29estimated

Primary completion2011-12-08actual

Study completion2011-12-08actual

Last update posted2017-06-14actual

Assets

Drug assets

GSK933776

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

•Probable mild Alzheimer's disease (MMSE 20-26) or mild cognitive impairment

•Increase in total tau or p-tau in CSF

•Decrease in amyloid beta in CSF

•Stable dose of cholinesterase inhibitors, memantine or selegine or no treatment

•Body weight less than 120 kg

•Willingness to comply with contraceptive methods if self or partner is of child-bearing potential

Exclusion criteria

•Any other cause of dementia

•Other significant neurologic or psychiatric illness

•Hachinski Ischemia Score >4

•More than 3 microbleeds on MRI

•Type 2 diabetes not controlled by diet

•Risk of cerebrovascular disease, cerebral haemorrhage or stroke

•History of systemic autoimmune disease

•Use of platelet anti-aggregates or anti-coagulants (Aspirin up to 325 mg/day is allowable)

•Use of chronic corticosteroids

•Uncontrolled hypertension in spite of antihypertensive medications

•Renal or hepatic insufficiency or clinically significant anaemia

•In nursing home care

•Contraindications to lumbar puncture or MRI

•Prior participation in therapeutic studies only after adequate wash-out period

Endpoints (5)

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

Amyloid biomarkers

Fluid / digital biomarkers

Global cognition

1 endpoint

Secondary/protocol endpoint

To assess the safety and tolerability after single dose of GSK933776 administration.

Time frame:three months

Mini-Mental State Examination (MMSE)

event count, event

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

The temporal changes of amyloid beta levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment

Time frame:22 hours

ratio, descriptive

Secondary/protocol endpoint

The temporal changes of total and free amyloid beta levels in plasma after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment

Time frame:Two months

ratio, descriptive

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

The temporal changes of Tau and phosphor Tau - 181 levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment

Time frame:22 hours

ratio, descriptive

Secondary/protocol endpoint

Estimated pharmacokinetic parameters of AUC, Cmax and Tmax in CSF and plasma at multiple time points with various intervals.

Time frame:three months

concentration, descriptive

Publications (2)

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.