A phase 2, double-blind, placebo-controlled study of the safety and tolerability of etanercept in patients with Alzheimer’s disease - Safety and Tolerability of Etanercept in Alzheimer's Disease
- Conditions
- Alzheimer's disease
- Registration Number
- EUCTR2009-013400-31-GB
- Lead Sponsor
- niversity of Southampton
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Demographic criteria:
Patients have to meet all of the following criteria at screening to enter the study:
1.Male or female patients aged > 54 years.
2.Have a minimum of 7 years of education.
3.Be able to hear, read, write and perform study neuropsychological tests in English.
4.Have adequate visual and auditory acuity to allow neuropsychological testing based on the research clinician’s judgement.
Medical and therapeutic criteria
All patients selected will have to:
1.Fulfil DSM-IV-TR criteria for diagnosis of dementia of the Alzheimer type
2.Have a diagnosis of probable Alzheimer’s Disease (NINCDS-ADRDA criteria) (McKhann et al 1984).
3.Mini Mental State Examination (MMSE) score < 27 and > 10 points.
4.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.
5.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients meeting any of the following criteria during screening or baseline evaluations will be excluded from the study:
General criteria
1.Refusal to provide informed consent/assent from all participants.
2.Absence of informant.
3.Unlikely to cooperate in the study, not able to attend scheduled examinations and visits, or not able to follow study instructions.
4.Participation in another study with administration of any investigational drug in the previous 3 months or already enrolled in another study.
Medical and therapeutic criteria
1.Parkinson’s Disease, Dementia with Lewy Bodies or clinically significant Parkinsonian symptoms.
2.Vascular disorder (modified Hachinski Ischaemic Scale score > 4)
3.Recent Transient Ischaemic Attack (TIA) – within the last 3 months
4.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).
5.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.
6.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
7.Patients with previous or present history of severe or unstable medical conditions (e.g. hypertension, diabetes left to the research clinician’s judgement).
8.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.
9.Surgical intervention planned during the study period.
10.Treatment with immunosuppressive drugs and/or oral prednisolone greater than 10mg/day within the past 90 days.
11.Treatment with Memantine within the past 3 months
12. Vaccination or immunization with any live vaccine (eg: polio, rubella, yellow fever) or the pneumococcal vaccine within the past 30 days.
13. Pregnancy or breast feeding.
14. Severe hepatic, renal or cardiac disease.
15. Previous use of a TNFa agent.
16. Known skin photosensitivity.
17. Infection in past 4 weeks or active infection.
18. Heart failure: New York Heart Association (NYHA) Grade 3-4.
19. History of blood disorders or current WCC = 3.5 x 109/l; platelet count = 100x109/l ; Hb = 10g/dl.
20. Active or latent tuberculosis.
21. Rheumatoid arthritis; psoriasis; psoriatic arthritis or anklylosing spondylitis.
22. Septic arthritis in past 12 months
23. Sepsis of prosthesis in past 12 months
24.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method