Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000047695
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
26/07/2005
Date last updated
26/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Brain and Ageing
Scientific title
Smoking cessation and the risk of cognitive decline in older men
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive decline 114 0
Quality of life, 115 0
Brain changes 116 0
Condition category
Condition code
Neurological 133 133 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nicotine patches + counselling
Intervention code [1] 61 0
Prevention
Comparator / control treatment
Counselling alone
Control group
Active

Outcomes
Primary outcome [1] 168 0
cognitive decline
Timepoint [1] 168 0
Secondary outcome [1] 367 0
Quality of life
Timepoint [1] 367 0
Secondary outcome [2] 368 0
Mood
Timepoint [2] 368 0
Secondary outcome [3] 369 0
Structural brain changes
Timepoint [3] 369 0

Eligibility
Key inclusion criteria
Men and women aged 70 years or over
Minimum age
70 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable and serious clinical condition (e.g., terminal cancer), current diagnosis of a major psychiatric disorder (e.g., depressive episode), history of severe head trauma or predisposition to seizure (such as brain tumour or stroke), current use of nicotine-replacement therapy, current use of other smoking-cessation treatments (such as bupropion), MMSE<24, other substance abuse or dependence (such as alcohol).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 184 0
Government body
Name [1] 184 0
National Health and Medical Research Council
Country [1] 184 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 137 0
None
Name [1] 137 0
none
Address [1] 137 0
Country [1] 137 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 949 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 949 0
Ethics committee country [1] 949 0
Australia
Date submitted for ethics approval [1] 949 0
Approval date [1] 949 0
Ethics approval number [1] 949 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36317 0
Address 36317 0
Country 36317 0
Phone 36317 0
Fax 36317 0
Email 36317 0
Contact person for public queries
Name 9250 0
Prof. Osvaldo P. Almeida
Address 9250 0
Unit of Geriatric Psychiatry
University of Western Australia
M573
35 Stirling Highway
Crawley WA 6009
Country 9250 0
Australia
Phone 9250 0
+61 8 92242855
Fax 9250 0
Email 9250 0
osvalm@cyllene.uwa.edu.au
Contact person for scientific queries
Name 178 0
Prof. Osvaldo P. Almeida
Address 178 0
Unit of Geriatric Psychiatry
University of Western Australia
M573
35 Stirling Highway
Crawley WA 6009
Country 178 0
Australia
Phone 178 0
+61 8 92242855
Fax 178 0
Email 178 0
osvalm@cyllene.uwa.edu.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
No additional documents have been identified.