Phase I Clinical trial of the safe use of perispinal Etanercept (Tumour Necrosis Factor-Alpha blocker) in Australian patients with progressive dementia

Griffith University0 个研究点目标入组 15 人开始时间: 2012年8月17日最近更新: 2020年1月13日

适应症

试验速览

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•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

•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)

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