Clinical trial NCT03631238: The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions
Official title: The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Cognitive Dysfunction
Hyperhomocysteinemia
Keywords: Cholesterol
Dementia
Homocysteine
Cognitive dysfunctions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 41
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 41 participants, randomly selected from out-patient neurology and psychiatry clinics , Assiut University Hospital.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Fifty hundred participants
* Participants are of both genders
* Aged 55 years old and over.

Exclusion Criteria:

* Patient with dementia.
* Renal and hepatic impairment.
* Parkinson's disease.
* Cerebrovascular stroke.
* Patient with chronic medical problems.
* Patients on statins.

Primary outcomes:
measure: correlations between serum total cholesterol and homocysteine levels and cognitive functions
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Michael W Ameen
Study officials:
affiliation: Assiut University
name: Nageh F El Gamal, MD
role: STUDY_CHAIR
References:
citation: de Champlain J, Wu R, Girouard H, Karas M, EL Midaoui A, Laplante MA, Wu L. Oxidative stress in hypertension. Clin Exp Hypertens. 2004 Oct-Nov;26(7-8):593-601. doi: 10.1081/ceh-200031904.
citation: Burns JM, Honea RA, Vidoni ED, Hutfles LJ, Brooks WM, Swerdlow RH. Insulin is differentially related to cognitive decline and atrophy in Alzheimer's disease and aging. Biochim Biophys Acta. 2012 Mar;1822(3):333-9. doi: 10.1016/j.bbadis.2011.06.011. Epub 2011 Jul 1.
citation: Cheng Y, Jin Y, Unverzagt FW, Su L, Yang L, Ma F, Hake AM, Kettler C, Chen C, Liu J, Bian J, Li P, Murrell JR, Hendrie HC, Gao S. The relationship between cholesterol and cognitive function is homocysteine-dependent. Clin Interv Aging. 2014 Oct 23;9:1823-9. doi: 10.2147/CIA.S64766. eCollection 2014.
citation: Ansari R, Mahta A, Mallack E, Luo JJ. Hyperhomocysteinemia and neurologic disorders: a review. J Clin Neurol. 2014 Oct;10(4):281-8. doi: 10.3988/jcn.2014.10.4.281. Epub 2014 Oct 6.