NCT01068353

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

2.9 years

First QC Date

February 10, 2010

Last Update Submit

April 22, 2014

Conditions

Alzheimer's Disease

Keywords

Alzheimer's diseaseDementiaTNF-alphaEtanercept

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (7)

  • 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

    6 months

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

    6 months

  • 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

    6 months

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

    6 months

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

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Etanercept

EXPERIMENTAL
Biological: Etanercept

Interventions

EtanerceptBIOLOGICAL

50 mg given as a once weekly subcutaneous injection

Also known as: Enbrel
Etanercept
PlaceboOTHER

Placebo injection given once weekly

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memory Assessment and Research Centre, Moorgreen Hospital

Southampton, Hampshire, SO30 3JB, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25934853DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 12, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Last Updated

April 23, 2014

Record last verified: 2014-04

Locations

GB(1)