Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001159842
Ethics application status
Approved
Date submitted
29/10/2012
Date registered
1/11/2012
Date last updated
1/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
New alternative therapeutical strategies in early senescence and immunosenescence
Scientific title
The effects of alternative therapies on cognitive deficits and immunosenescence in community aged subjects
Secondary ID [1] 281465 0
none
Universal Trial Number (UTN)
U1111-1136-3604
Trial acronym
AGEing
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 287715 0
Immunosenescence 287716 0
Condition category
Condition code
Mental Health 288050 288050 0 0
Studies of normal psychology, cognitive function and behaviour
Inflammatory and Immune System 288059 288059 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients will be randomly divided in five different subgroups, checking afterwards that there are not any significant differences between the groups, regarding their age, sex, neuroimagistic findings, and their cognitive status reflected by Mini Mental State Examination (MMSE) scores. The mini–mental state examination (MMSE) is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is used to estimate the severity of cognitive impairment and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. The subgroups will receive the treatment orally, for at least one year, to a maximum duration of two years. The overall duration of treatment will be decided after the subject's assessment at one year, upon completing the evaluation tests performed at that time. The study subgroups will receive the treatment as follows:
1. subgroup A that will comprise elderly subjects diagnosed with mild cognitive impairment (MCI), having the MMSE score between 21-28 points). This subgroup will be treated
with Piracetam 4 tablets/day (daily dose: 1600 mg);
2. subgroup B that will comprise elderly subjects diagnosed with MCI, that will be treated with Rhodiola-rosea, 2 capsules/day (500 mg daily);
3. subgroup C that will comprise elderly subjects diagnosed with MCI,which will be treated with Selezin ACE (Selenium 100 mcg, Zinc 15 mg; Vitamin A 1000 mcg, Vitamin B6 2,20 mg, Vitamin C 90 mg, Vitamin E 15 mg) and Coenzyme Q (10 mg daily);
4. subgroup D that will comprise elderly subjects with MCI, treated with Selezin ACE, Coenzyme Q (10 mg daily) and Rhodiola Rosea (500 mg daily).
Intervention code [1] 285956 0
Treatment: Other
Comparator / control treatment
There will be two control groups:

A control group that will comprise age-matched elderly subjects (over 65 years) without MCI (MMSE = 30 points) and without treatment (including placebo).

A control group (subgroup E) that will comprise elderly subjects with MCI (MMSE = 21-28 points), receiving placebo (a pill, identical in taste and appearance, but without the active ingredient).
Control group
Placebo

Outcomes
Primary outcome [1] 288259 0
Mild cognitive impairment improvement, as assessed by MMSE, clock, and Raven tests.
Timepoint [1] 288259 0
Initial screening, first assessment at 6 months, second assessment at one year.
Secondary outcome [1] 299705 0
Immunosenescence improvement, as assessed byimmune phenotype of peripheral blood CD8+ T cells.
Timepoint [1] 299705 0
Initial screening, and assessment at one year.

Eligibility
Key inclusion criteria
Subjects with 65 years of age and older than 65;
Subjects diagnosed with MCI (MMSE score =21-28 points).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects younger than 65 years;
Subjects with MCI due to major depressive disorder and schizophrenia;
Subjects with moderate and severe cognitive impairment (MMSE score under 21 points).

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)
MCI individuals will be identified by screening subjects aged over 65 years from Arad county in western part of Romania, consenting to participate in the study. Neuropsychological scales will be administered, to assess the cognitive functions (MMSE score between 21- 28 points, Raven test and Clock test).
The subjects who will be selected for this study have a MMSE score between 21-28 points, and memory-related symptoms.
The subjects will be randomly divided in five different subgroups, checking afterwards that there are not any significant differences between the groups, regarding their age, sex, neuroimagistic findings, and their cognitive status reflected by MMSE scores. The allocation to intervention will be performed with concealment, by using sealed opaque envelopes .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The subjects participating in the study will be randomly divided between the five treatment groups (subgroups A, B, C, D and E), receiving different therapeutical schemes. The selection of the subjects into the different subgroups will be performed by simple randomisation, using sealed opaque envelopes, each envelope containing the study subgroups:
1. subgroup A that will comprise elderly subjects diagnosed with MCI (MMSE = 21-28 points), that will be treated
with Piracetam 4 tablets/day (daily dose: 1600 mg);
2. subgroup B that will comprise elderly subjects diagnosed with MCI, that will be treated with Rhodiola-rosea, 2 capsules/day (500 mg daily);
3. subgroup C that will comprise elderly subjects diagnosed with MCI,which will be treated with Selezin ACE (Selenium 100 mcg, Zinc 15 mg; Vitamin A 1000 mcg, Vitamin B6 2,20 mg, Vitamin C 90 mg, Vitamin E 15 mg) and Coenzyme Q (10 mg daily);
4. subgroup D that will comprise elderly subjects with MCI, treated with Selezin ACE, Coenzyme Q (10 mg daily) and Rhodiola Rosea (500 mg daily).
5. subgroup E, that will comprise elderly subjects with MCI (MMSE = 21-28 points), receiving placebo.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 4657 0
Romania
State/province [1] 4657 0
Arad county

Funding & Sponsors
Funding source category [1] 286217 0
Government body
Name [1] 286217 0
Romanian National Council of Research
Country [1] 286217 0
Romania
Primary sponsor type
University
Name
University of Medicine and Pharmacy "Victor Babes" Timisoara
Address
E. Murgu Sq. #2A, Timisoara, Romania
Country
Romania
Secondary sponsor category [1] 285033 0
University
Name [1] 285033 0
"Vasile Goldis" Western University of Arad
Address [1] 285033 0
Revolution Bld. no. 94, Arad
Country [1] 285033 0
Romania

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288292 0
Ethics Committee
Ethics committee address [1] 288292 0
Ethics committee country [1] 288292 0
Romania
Date submitted for ethics approval [1] 288292 0
01/10/2007
Approval date [1] 288292 0
15/10/2007
Ethics approval number [1] 288292 0
21/2007

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

Contacts
Principal investigator
Name 34884 0
Address 34884 0
Country 34884 0
Phone 34884 0
Fax 34884 0
Email 34884 0
Contact person for public queries
Name 18131 0
Associate Professor Daniel Cioca, M.D., Ph.D.
Address 18131 0
University of Medicine and Pharmacy "Victor Babes" Timisoara,
Eftimie Murgu Sq. no. 2A, 300041, Timisoara
Country 18131 0
Romania
Phone 18131 0
+40-720056934
Fax 18131 0
+40-256-415681
Email 18131 0
[email protected]
Contact person for scientific queries
Name 9059 0
Associate Professor Daniel Cioca, M.D., Ph.D.
Address 9059 0
University of Medicine and Pharmacy "Victor Babes" Timisoara,
Eftimie Murgu Sq. no. 2A, 300041, Timisoara
Country 9059 0
Romania
Phone 9059 0
+40-720056934
Fax 9059 0
+40-256-415681
Email 9059 0
[email protected]

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

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