The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions

Completed

• Conditions: Hypercholesterolemia; Cognitive Dysfunction; Hyperhomocysteinemia
• Interventions: Diagnostic Test: Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.

• Registration Number: NCT03631238
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2018-01-15
• Primary Completion: 2018-06-01
• Status Verified: 2018-08
• Study Completion: 2018-08-01
• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Apparently normal participants	Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.	Participants are not complaining from any cognitive decline are subjected to cognitive and cholesterol and homocysteine levels assessment.

Primary Outcome Measures

Name	Time	Method
correlations between serum total cholesterol and homocysteine levels and cognitive functions	1 hour	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.

Trial Locations

Locations (1)

Michael W Ameen; 🇪🇬 Assiut, Egypt