Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000324516
Ethics application status
Approved
Date submitted
24/07/2006
Date registered
27/07/2006
Date last updated
27/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The Shepherd Foundation Study into Alzheimer's Disease
Scientific title
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
Secondary ID [1] 285 0
Therapeutic Goods Association (TGA) Clinical Trial Notification (CTN): TGA CTN 2006/59
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate Alzheimer's disease 1294 0
Condition category
Condition code
Neurological 1384 1384 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1225 0
Treatment: Drugs
Comparator / control treatment
1) Placebo MKTVIF75HV alone. Duration: 2 months. Dose: initially 18 000 international units orally per day.
2) Placebo ASFSADNS. Duration: 48 hours. Dose 60 international units intranasal qid.
Control group
Placebo

Outcomes
Primary outcome [1] 1888 0
Cognition
Timepoint [1] 1888 0
Alzheimer's disease assessment scale cognitive subscale (ADAS-cog) at 2 months (MKTVIF75HV) and by Wechsler Memory Scale-revised logical memory (WMS-RLM) subtest for immediate and 30-minute delayed recall of two 25 information-bit stories at 48 hours of treatment (ASFSADNS).
Secondary outcome [1] 3330 0
Disability at 2 months of MKTVIF75HV versus placebo MKTVIF75HV measured by The Disability Assessment in Dementia (DAD).
Timepoint [1] 3330 0
At 2 months
Secondary outcome [2] 3331 0
Geriatric Depression Scale (GDS)
Timepoint [2] 3331 0
At 2 months of parallel design and 48 hours of factorial design.
Secondary outcome [3] 3332 0
Brief Pain Inventory (BPI) verbal modification.
Timepoint [3] 3332 0
At 2 months of parallel design and 48 hours of factorial design.

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by offsite statistician after cohort enrolled in study with allocation schedule provided to hospital pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation stratified by diabetes and other drug therapy for Alzheimer's disease
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Test of MKTVIF75HV is parallel. Test of ASFSADNS is factorial. See details under Intervention above
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1518 0
Charities/Societies/Foundations
Name [1] 1518 0
The Shepherd Foundation Study into Alzheimer's Disease
Country [1] 1518 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 1333 0
None
Name [1] 1333 0
Nil
Address [1] 1333 0
Country [1] 1333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2942 0
Royal Melbourne Hospital
Ethics committee address [1] 2942 0
Ethics committee country [1] 2942 0
Australia
Date submitted for ethics approval [1] 2942 0
Approval date [1] 2942 0
Ethics approval number [1] 2942 0
2005.215

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35273 0
Address 35273 0
Country 35273 0
Phone 35273 0
Fax 35273 0
Email 35273 0
Contact person for public queries
Name 10414 0
Dr Mark Stein
Address 10414 0
Department of Diabetes and Endocrinology
The Royal Melbourne Hospital
Parkville
Victoria 3050
Country 10414 0
Australia
Phone 10414 0
(03) 9342 7365
Fax 10414 0
Email 10414 0
mark.stein@mh.org.au
Contact person for scientific queries
Name 1342 0
Dr Mark Stein
Address 1342 0
Department of Diabetes and Endocrinology
The Royal Melbourne Hospital
Parkville
Victoria 3050
Country 1342 0
Australia
Phone 1342 0
(03) 9342 7365
Fax 1342 0
Email 1342 0
mark.stein@mh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVitamin Supplementation and Dementia: A Systematic Review.2022https://dx.doi.org/10.3390/nu14051033
N.B. These documents automatically identified may not have been verified by the study sponsor.