The Shepherd Foundation Study into Alzheimer's Disease
Randomised placebo-controlled double- blind study of unregistered drug MKTVIF75HV and unregistered drug ASFSADNS on cognition and disability in mild to moderate Alzheimer's disease
Melbourne Health
60 participants
Jul 28, 2006
Interventional
Conditions
Summary
The aim of the study is to test two new drug treatments for mild to moderate Alzheimer's disease. Subjects and assessors are both blind to treatment allocation.
Eligibility
Exclusion Criteria1
- Prominent dysphasia.Defined abnormalities/levels on screening blood tests.History of renal calculi.History of GIT lesions which may affect absorption of MKTVIF75HV.Febrile illness greater than one day and/or IVI antibiotics and/or intravenous sedation or general anaesthesia within one month prior to first cognitive assessment.Past cranial neurosurgery, epilepsy or multiple sclerosis. Type one diabetes. Lesions which may affect compliance with study regimen.
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Interventions
1) MKTVIF75HV alone. Duration: 2 months. Dose: initially 18 000 international units orally per day. 2) ASFSADNS. Duration: 48 hours. Dose 60 international units intranasal qid. The ASFSADNS intervention is a factorial design intervention at the end of the 2 month parallel design MKTVIF75HV. That is, after 2 months of parallel design MKTVIF75HV versus placebo MKTVIF75HV there will be a further 48 hours of factorial design: ASFSADNS with MKTVIF75HV versus ASFSADNS with placebo MKTVIF75HV versus placebo ASFSADNS with MKTVIF75HV versus placebo ASFSADNS with placebo MKTVIF75HV
Locations(1)
View Full Details on ANZCTR
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ACTRN12606000324516