None listed
Conditions
Brief summary
Etanercept, when given by injection overlying the spine, has been reported to be very beneficial for treatment of patients with moderate Alzheimer’s disease and is a beneficial treatment for other related forms of dementia in multiple published, peer-reviewed scientific studies. The primary aim of the study is to determine the safety and tolerability of perispinal injection of Etanercept in subjects with progressive dementia with a focus on Australian Alzheimer's sufferers.
Interventions
Etanercept (Enbrel) 25mg or less prepared in 1ml syringe as 25mg/1ml, injected subcutaneously at the back of the neck in an area that drains into the blood supply that goes towards the brain spaces. The treatment consists of a weekly injection of Etanercept over a period of 4 weeks by a trained and certified medical practitioner, followed by a follow-up assessment on the 5th week. Participant will be tilted forward on a purpose built tilt bed after the injection lowering the head for 5 minutes t
Etanercept (Enbrel) 25mg or less prepared in 1ml syringe as 25mg/1ml, injected subcutaneously at the back of the neck in an area that drains into the blood supply that goes towards the brain spaces. The treatment consists of a weekly injection of Etanercept over a period of 4 weeks by a trained and certified medical practitioner, followed by a follow-up assessment on the 5th week. Participant will be tilted forward on a purpose built tilt bed after the injection lowering the head for 5 minutes to aid the Etanercept enter the brain spaces.
Sponsors
Griffith University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
70 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
1) informed consent (i.e., authority received from participant themselves and/or an approved Surrogate Decision Maker/Guardian according to the appropriate Guardianship and Administration Tribunal (GAAT) in QLD or NSW. 2) Fulfil Diagnostic & Statistical Manual (DSM-IV-TR) criteria for diagnosis of dementia of the Alzheimer type 3) Have a diagnosis of probable Alzheimer's Disease meeting National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's disease. 4) CT/MRI brain scans or initial SPECT exam compatible with diagnosis of AD. 5) Age of onset of AD at 70 years of age or close to this. 6) MMSE 10-20, and prescribed Donepezil, dose should be stable for at least 3 months before the trial, and should be unchanged during the trial
Exclusion criteria
1) Parkinson's Disease, Dementia with Lewy Bodies or clinically significant Parkinsonian symptoms. 2) Hallucinations, delirium –associated with Lewy Bodies. 3) Diagnosis of Aphasia and/or Bizarre behaviour (such as violence) – often attributes of SD or FTD. 4) Rapidly declining patients - AD progression is slow. Rapid decline indicates another factor is involved. 5) Patients who show ENBREL contraindications: - History of active or chronic infection - Lymphoma, active or in the past Cancer - Multiple Sclerosis - Demyelinating disease - Uncontrolled diabetes mellitus - Patients prescribed Kineret (Anakinra) or Abatacept) 6) Patients who have or are: - Hematologic disease - Congestive Heart Failure - Immunosuppressed (including patients prescribed other immunosuppressive drugs e.g. glucocorticoids, NSAIDS)
Outcome results
None listed