New alternative therapeutical strategies in early senescence and immunosenescence
The effects of alternative therapies on cognitive deficits and immunosenescence in community aged subjects
University of Medicine and Pharmacy "Victor Babes" Timisoara
400 participants
Feb 1, 2008
Interventional
Conditions
Summary
The final aim of the study is the significant improvement of the health state of the population, with special reference the elderly people, thus improving the quality of life, with the reduction of costs necessary for the medical services by developing preventive and therapeutical advanced procedures, extremely efficient for the specific dysfunctions which appear in the elderly people. The main objective of the trial is the early diagnosis for mild cognitive impairment and to assess the efficacy of alternative and complementary therapies used on elderly subjects.
Eligibility
Inclusion Criteria2
- Subjects with 65 years of age and older than 65;
- Subjects diagnosed with MCI (MMSE score =21-28 points).
Exclusion Criteria3
- 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).
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Interventions
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).
Locations(1)
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ACTRN12612001159842