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STEADI-09

CompletedPhase 2

Safety and Tolerability of Etanercept in Alzheimer's Disease

A Phase 2, Double-blind, Placebo-controlled Study of the Safety and Tolerability of Etanercept in Patients With Alzheimer's Disease

Asset

Etanercept

Listed sites

1

Recruiting sites

-

Enrollment

41

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-27

Primary endpoint

•Adverse events and serious adverse events

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

Eudract number2009-013400-31
NCT IDNCT01068353
Org study IDSTEADI-09

Timeline

Milestones

Study first posted2010-02-12estimated
Study start2011-01 (month precision)
Primary completion2013-12actual (month precision)
Last update posted2014-04-23estimated

Assets

Drug assets

Etanercept

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female patients aged > 54 years
•Have a minimum of 7 years of education
•Be able to hear, read, write and perform study neuropsychological tests in English
•Have adequate visual and auditory acuity to allow neuropsychological testing based on the research clinician's judgement
•Fulfil Diagnostic \& Statistical Manual (DSM-IV-TR)criteria for diagnosis of dementia of the Alzheimer type
•Have a diagnosis of probable Alzheimer's Disease (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria)
•Mini Mental State Examination (MMSE) score < 27 and > 10 points.
•To be currently taking and have been taking a cholinesterase inhibitor for a minimum period of 3 months prior to the day of inclusion into the study or to have been not been taking a cholinesterase inhibitor for a minimum period of 3 months prior to the day of inclusion into the study
•Have an informant who spends at least 24 hours per week with the patient and may be a close friend or a neighbour, not necessarily a close relative, spouse, son or daughter. He/she should be the same throughout the study and should be present at all visits. If it becomes necessary, a change of informant can be made but this must be clearly documented

Exclusion criteria

•Inability or refusal to provide informed consent from patient or caregiver
•Absence of informant
•Unlikely to cooperate in the study, not able to attend scheduled examinations and visits, or not able to follow study instructions
•Participation in another study with administration of any investigational drug in the previous 3 months or already enrolled in another study
•Parkinson's Disease, Dementia with Lewy Bodies or clinically significant Parkinsonian symptoms
•Vascular disorder (modified Hachinski Ischaemic Scale score > 4)
•Recent Transient Ischaemic Attack (TIA) - within the last 3 months
•Signs of major cerebrovascular disease on MRI or CT scan, if performed prior to entry into study (i.e. presence of infarction in greater than 25% of white matter, more than 1 lacune within basal ganglia, more than 2 lacunes in white matter)
•Any other previous or ongoing chronic or recurrent disease of the central nervous system, including demyelinating disease or psychiatric diseases, that may have an impact on cognitive performance, left to the research clinician's judgement
•Any of the following laboratory abnormalities at the screening visit:

i) Clinically significant Vitamin B12 levels less than the lower limit of normal ii) Clinically significant folate levels less than the lower limit of normal iii) Clinically significant thyroid-stimulating hormone (TSH) levels greater than the upper limit of normal and a clinically significant free thyroxine (FT4) level lower than the lower limit of normal

•Patients with previous or present history of severe or unstable medical conditions (e.g. hypertension, diabetes left to the research clinician's judgement)
•Current alcohol >35 units per week for men, or >28 units per week for women, or drug abuse at the discretion of the research clinician
•Surgical intervention planned during the study period.
•Treatment with immunosuppressive drugs and/or oral prednisone greater than 10mg/day within the past 90 days
•Treatment with Memantine within the past 3 months
•Vaccination or immunization with any live vaccine (eg: polio, rubella, yellow fever) or the pneumococcal vaccine within the past 30 days.
•Pregnancy or breast feeding.
•Severe hepatic, renal or cardiac disease.
•Previous use of a Tumour Necrosis Factor-alpha (TNFα) agent.
•Known skin photosensitivity.
•Infection in past 4 weeks or active infection.
•Heart failure: New York Heart Association (NYHA) Grade 3-4.
•History of blood disorders or current WCC ≤ 3.5 x 109/l; platelet count ≤ 100x109/l ; Hb ≤ 10g/dl.
•Active or latent tuberculosis
•Rheumatoid arthritis; psoriasis; psoriatic arthritis or ankylosing spondylitis
•Septic arthritis in past 12 months
•Sepsis of prosthesis in past 12 months
•Chronic leg ulcers
•Indwelling urinary catheter
•Pulmonary fibrosis
•History of neoplasms / malignancies in past 5 years
•Pre-malignant conditions including Barrett's oesophagus; cervical dysplasia; large bowel polyps
•Any relevant acute or chronic abnormality detected during the physical and neurological examinations. Electrocardiogram (ECG) or laboratory tests likely to interfere with the study evaluations in the research clinician's judgement
•Previous exposure to amyloid vaccines, monoclonal antibodies or intravenous immunoglobulins meant to treat Alzheimer's disease

Endpoints (8)

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

Global cognition
2
Behavior / neuropsychiatric
2
Other (unclassified)
2
Fluid / digital biomarkers
1
Safety / tolerability / PK
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Difference in change in Alzheimer's Disease Assessment Scale - Cognitive Section (ADAS-cog) total score between treated and placebo groups from baseline to end point at 6 months

Time frame:6 months

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Difference in change in Mini-Mental State Examination (MMSE) total score between treated and placebo groups from baseline to end point at 6 months

Time frame:6 months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Difference in change in Neuropsychiatric Inventory (NPI) total score between treated and placebo groups from baseline to end point at 6 months

Time frame:6 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Difference in change in Sickness Behaviour Scale between treated and placebo groups from baseline to end point at 6 months

Time frame:6 months

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

To examine the effects of etanercept on inflammatory markers in the cerebrospinal fluid (CSF) of patients with Alzheimer's disease, and the relationship of these factors with clinical outcome

Time frame:6 months

descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Frequency of adverse events and serious adverse events (the study is a Phase II safety trial)

Time frame:6 months

event count, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Difference in change in Clinician's Global Impression of Change (CGIC) and Carer's Impression of Change (Carer-IC) total score between treated and placebo groups from baseline to end point at 6 months

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

To establish whether a pro-inflammatory baseline cytokine profile predicts better response to treatment with etanercept

Time frame:6 months

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.