An observational study in Mild Cognitive Impairment, sponsored by Pamlab, Inc.. Status unknown at 1 site in United States. Open to participants aged 55 Years to 89 Years. Per ClinicalTrials.gov, last updated 2014-03-24.
Sponsored by Pamlab, Inc. (part of Alfasigma S.p.A.) · Observational
This retrospective analysis of de-identified data from 700 charts of consecutive patients from this patient population is to investigate the prevalence of hyperhomocysteinemia and associated metabolic abnormalities in this naturalistic grouping of patients with various stages of cognitive loss and diagnosed with various types of dementia.
A single-center, retrospective review of the medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss including analysis of:
Laboratory values of interest: homocysteine, methylmalonic acid, CRP, BNP, CO2, TSH, Fe/TIBC, RPR/TPPA/FTA-ABS, and if available, folic acid and B12 levels ordered by primary care providers.
Neuropsychological tests of executive function, memory and affect:
Wechsler Memory Scale-Revised (WMS-R) or Fourth Edition (WMS-IV)
Sub-group analysis of MRI volumetrics and PET scans when available. Sequentially pulled from June 1, 2009 to September 2011
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 700 is above the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Pamlab, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss.
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:
Change from Baseline in Levels of Homocysteine Over Time
To analyze homocysteine levels, cognitive test scores and depression level to determine the prevalence of hyperhomocysteinemia and associated metabolic abnormalities and compare results of patients on Cerefolin NAC® alone to patients on Cerefolin NAC® in combination with standard of care memory and/or depression medications.
Time frame: Week 6, Week 12, and Quaterly Thereafter @ 6 Month Intervals
To evaluate the safety and tolerability of Cerefolin NAC® based on adverse events, discontinuation due to intolerability and compliance.
Time frame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals
Examine the demographics, medical co-morbidities present and affective and cognitive characteristics of the group of patients demonstrating hyperhomocysteinemia compared with the group without hyperhomocysteinemia in a dementia population.
Time frame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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