None listed
Conditions
Brief 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.
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 versu
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
Sponsors
Melbourne Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Mild to moderate Alzheimer's disease (Mini mental state examination score of 12-24). The Alzheimer's disease was diagnosed by a specialist or specialist clinic. There may be co-existing cerebrovascular disease or Parkinsonism subject to the exclusion criteria. On stable dose anticholinesterase therapy for at least 3 months or off such therapy (because failed it or could not tolerate it) for at least 3 months. Conversant in English. Consent obtained.
Exclusion criteria
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.
Outcome results
None listed