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Trial registered on ANZCTR


Registration number
ACTRN12612000785808
Ethics application status
Approved
Date submitted
23/07/2012
Date registered
24/07/2012
Date last updated
24/04/2020
Date data sharing statement initially provided
24/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The chronic effects of Bacopa on cognitive performance in Alzheimer's patients - A pilot study
Scientific title
The chronic effects of Bacopa on cognitive performance in Alzheimer's patients - A pilot study
Secondary ID [1] 280841 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease 286907 0
Condition category
Condition code
Neurological 287228 287228 0 0
Alzheimer's disease
Alternative and Complementary Medicine 287229 287229 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bacopa Monniera (Brahmi), 160mg per tablet, 2x Tablets to be consumed orally, daily for 90 day duration
Intervention code [1] 285263 0
Treatment: Other
Comparator / control treatment
Placebo controlled, Identical in appearance, 2x tablets to be consumed orally, daily for 90 days
Control group
Placebo

Outcomes
Primary outcome [1] 287513 0
Cognitive performance - score on the Alzheimer's Disease Assessment Scale- Cognition (ADAS-COG)
Timepoint [1] 287513 0
baseline and 90 days after intervention commencement
Primary outcome [2] 287514 0
Cognitive performance - Mini Mental State Examination (MMSE) score
Timepoint [2] 287514 0
baseline and 90 days after intervention commencement
Primary outcome [3] 287515 0
Performance on Cognitive Drug Research (CDR) computerised test battery
Timepoint [3] 287515 0
baseline and 90 days after intervention commencement
Secondary outcome [1] 298301 0
Mood, as measured by the Visual Analog Mood Sclaes (VAMS)
Timepoint [1] 298301 0
baseline and 90 days after intervention commencement
Secondary outcome [2] 298302 0
Quality of life, as measure by Cornell-Brown Scale for Quality of life in Dementia, and the Assessment of Quality of Life.
Timepoint [2] 298302 0
baseline, 30, 60 and 90 days after intervention commencement
Secondary outcome [3] 298303 0
Cognitive performance - Swinburne Computerised Cogntiive Assessment Battery (SUCCAB)
Timepoint [3] 298303 0
baseline and 90 days after intervention commencement
Secondary outcome [4] 298304 0
mean response time on an Inspection time task
Timepoint [4] 298304 0
baseline and 90 days after intervention commencement

Eligibility
Key inclusion criteria
Diagnosis of mild to moderate Alzheimer's disease
Aged 60 and above
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
less than 60 years of age
History of, or current psychiatric illness
Neurological diseases (other than Alzheimers)
Suffering from Endocrine, gastrointestinal or bleeding disorders
A history of chronic illness or infection
Pregnant or lactating
current use of medications including; anticoagulants, antidepressants, anti-psychotics, anxyolitics, anti-parkinsons.
current use of illicit drugs, cognitive enhancing drugs, or vitamin and herbal supplements

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)
After successfully completing the phone screen, diagnosis confirmation and practice session, participants will be randomly allocated to receive either treatment A or B (active or placebo) on their first testing day. This will be done by a randomised computer number sequence generator. At the conclusion of the baseline test session they will receive a 90 day supply of the treatment. A disinterested third party will be responsible for the blinding procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party will generate the randomisation sequence using a computer sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285624 0
University
Name [1] 285624 0
Swinburne University of Technology
Address [1] 285624 0
John Street, Hawthorn, VIC, 3122
Country [1] 285624 0
Australia
Funding source category [2] 285637 0
Charities/Societies/Foundations
Name [2] 285637 0
Barbara Dicker Foundation
Address [2] 285637 0
John Street, Hawthorn, VIC, 3122
Country [2] 285637 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John Street, Hawthorn, VIC, 3122
Country
Australia
Secondary sponsor category [1] 284472 0
None
Name [1] 284472 0
Address [1] 284472 0
Country [1] 284472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287637 0
Alfred Hostpital Ethics Committee
Ethics committee address [1] 287637 0
Alfred Hospital Commercial Road MELBOURNE VIC 3004
Ethics committee country [1] 287637 0
Australia
Date submitted for ethics approval [1] 287637 0
Approval date [1] 287637 0
11/07/2012
Ethics approval number [1] 287637 0
1/12/0193

Summary
Brief summary
The goal of this study is to investigate the efficacy of Bacopa as an adjunctive therapy to existing pharmaceutical treatments for Alzheimers patients. The study will test individuals diagnosed with mild to moderate Alzheimer's Disease, in a double blind, placebo controlled, parallel groups design. Particpants will either take Bacopa monniera for 90 days or a placebo for 90 days. Participants will attend an initial pre-screening and pratice session, baseline session and one follow-up testing session following 90 days of supplementation. During these session, participants will be required to complete several cognitive tests, which have been widely used to assess both enhancement and impairment of human cognitive performance. Mood and quality of life will also be assessed.
It is hypothesised that measures of attention, processing speed and memory will improve in the Bacopa group relative to the placebo group. A further aim of the study is to investigate differences in mood and quality of life in the Bacopa treatment group relative to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34432 0
Address 34432 0
Country 34432 0
Phone 34432 0
Fax 34432 0
Email 34432 0
Contact person for public queries
Name 17679 0
Robyn Cockerell
Address 17679 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H99, PO BOX 218
Hawthorn Vic, 3122
Country 17679 0
Australia
Phone 17679 0
+61 3 9214 5782
Fax 17679 0
Email 17679 0
rcockerell@swin.edu.au
Contact person for scientific queries
Name 8607 0
Con Stough
Address 8607 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H99, PO BOX 218
Hawthorn Vic, 3122
Country 8607 0
Australia
Phone 8607 0
+61 3 9214 8167
Fax 8607 0
Email 8607 0
cstough@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
No Results