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Alzheimer's DiseasePhase 2STEADI-09NCT01068353

Safety and Tolerability of Etanercept in Alzheimer's Disease

A Phase 2 study testing Etanercept in people with Alzheimer's Disease, run by University of Southampton at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of the study is to determine the safety and tolerability of etanercept in subjects with Alzheimer's Disease. The effects of etanercept on cognitive, behavioural, functional and immunological outcomes will be examined as secondary aims. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Etanercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2011to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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)
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  • 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:
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Memory Assessment and Research Centre, Moorgreen Hospital

    Southampton, Hampshire, SO30 3JB

Other trials in United Kingdom

About this study

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

The primary aim of the study is to determine the safety and tolerability of etanercept in subjects with Alzheimer's Disease. The effects of etanercept on cognitive, behavioural, functional and immunological outcomes will be examined as secondary aims.

Being tested
Etanercept, Placebo
Keywords
Alzheimer's disease, Dementia, TNF-alpha, Etanercept
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtanerceptBiological

    Also called Enbrel

    50 mg given as a once weekly subcutaneous injection

  • PlaceboOther

    Placebo injection given once weekly

Study groups in NCT01068353
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo
EtanerceptExperimentalNot described
Receives: Biological: Etanercept

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (7)

  1. 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

    Measured: 6 months

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

    Measured: 6 months

  3. 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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  7. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01068353
Sponsor's protocol ID
STEADI-09
Other IDs
2009-013400-31, 2009
Acronym
STEADI-09
Status last verified
Apr 2014
First submitted
10 Feb 2010
Last updated
23 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Butchart J, Brook L, Hopkins V, Teeling J, Puntener U, Culliford D, Sharples R, Sharif S, McFarlane B, Raybould R, Thomas R, Passmore P, Perry VH, Holmes C. Etanercept in Alzheimer disease: A randomized, placebo-controlled, double-blind, phase 2 trial. Neurology. 2015 May 26;84(21):2161-8. doi: 10.1212/WNL.0000000000001617. Epub 2015 May 1.

    PubMed 25934853

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etanercept in people with Alzheimer's Disease, run by University of Southampton at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events and serious adverse events (the study is a Phase II safety trial) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01068353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.

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