An observational study in Hypercholesterolemia, Cognitive Dysfunction and Hyperhomocysteinemia, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-16.
Sponsored by Assiut University · Observational
The study evaluates if the relationship between total serum cholesterol is dependent on the total serum homocysteine. Fasting blood samples will taken from participants and two batteries of cognitive scales will be used to asses any cognitive decline.
The relationship between total serum cholesterol (TC) levels and cognition remains wily.
Some studies suggested that high TC level in old peoples is associated with a decreased risk of dementia.
Other studies have indicated that hypercholesterolemia may be a risk factor for cognitive decline and Alzheimer's disease (AD).
But a recent study published in 2014 by Cheng and colleagues, showed that, an inverse U-shaped relationship between total cholesterol level and cognitive score was found only in participants with normal homocysteine levels. Indicating that both low and high total serum cholesterol were associated with lower cognitive scores, ended to the relationship between cholesterol levels and cognitive function depends upon homocysteine levels, suggesting an interactive role between cholesterol and homocysteine on cognitive function in the elderly peoples.
The effect of high serum homocysteine (HHcy) levels on cognition was overwhelming regardless of the serum cholesterol levels but in peoples with normal homocysteine levels, both low and high cholesterol levels may be detrimental to cognitive health.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's enrollment of 41 is below the median of 1,000 across 144 observational studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The study included 41 participants, randomly selected from out-patient neurology and psychiatry clinics , Assiut University Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants are not complaining from any cognitive decline are subjected to cognitive and cholesterol and homocysteine levels assessment.
Diagnostic Test: Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.
all participant are subjected to cognitive assessment by psychometric tests by using the arabic version of Mini Mental State Exam (MMSE) and Memory Assessment Scale (MAS). Blood samples were collected in the morning using 10 mL yellow top (plain) Vacutainer tubes. Lipid profile (triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)) were measured by Assiut university labs using Cholesterol Kits and analyzed by COBAS Integra analyzer. Total cholesterol levels were calculated using the sum of the LDL and HDL plus one-fifth of triglyceride levels. Samples of serum homocysteine are collected, centrifuged to separate plasma within 30 minutes after venipuncture and stored in specialized container in the Department of Clinical Pathology at (-20◦C) temperature. Total homocysteine was measured by ELISA technique, Sinogen kits (Research Use Only) and Statfax-2100 microplate analyzer.
correlations between serum total cholesterol and homocysteine levels and cognitive functions
Blood samples were collected after an overnight fast by using 10 mL plain tubes. Lipid profile was measured by using Cholesterol Kits and analyzed by COBAS Integra analyzer. Total cholesterol levels were measured using the sum of the LDL and HDL plus one-fifth of triglyceride levels. Samples of serum homocysteine (Hcy) are stored in specialized container at (-20◦C) temperature. Total Hcy was measured by ELISA technique, Sinogen kits and Statfax-2100 micro-plate analyzer. Cognitive functions were measured by using the Arabic version of: the 30 points Mini Mental State Exam (MMSE) and the Memory Assessment Scale (MAS) which consists of 12 subtests and the degree of 100 points. The mean of total MAS plus MMSE degrees is used (e.g., (100+30)/2=65 Points which is the maximum score). High, normal and low cholesterol level is compared to the mean of cognitive score only in participants with normal homocysteine levels (below 14 umol/l), higher levels of Hcy is excluded.
Time frame: 1 hour
Ran from Jan 2018 to primary completion in Jun 2018, 4 months.
Of 51 observational studies under Hypercholesterolemia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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