Clinical trial NCT01594541: A Retrospective Analysis of Cerefolin NAC® in Cognitively Impaired Patients
Official title: Hyperhomocysteinemia in a Mild Cognitive Impairment and Dementia Population: the Effect of Treatment With Cerefolin NAC® in a Naturalistic Community-based Dementia Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Keywords: hyperhomocysteinemia
dementia
depression
vitamin B12
mild cognitive impairment
alzheimer's
Lead sponsor: Pamlab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clionsky Neuro Systems Inc.
First posted: 2012-05-09
Enrollment: 700
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical charts of 700 de-identified elderly patients who underwent evaluation and treatment for cognitive loss.

Brief summary: 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.

Detailed description: 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)

  * Logical Memory -Delayed Recall, Scaled Score
  * Visual Reproduction-Delayed Recall, Scaled Score
* Shopping List Test, Delayed Recall
* Trailmaking A and B Tests
* Verbal Absurdities subtest of the Stanford Binet, Form L-M
* Proverbs Test
* Memory Orientation Screening Test
* Folstein Mini-Mental State Exam
* Geriatric Depression Scale, 15 items

Sub-group analysis of MRI volumetrics and PET scans when available. Sequentially pulled from June 1, 2009 to September 2011

Eligibility criteria: Inclusion Criteria:

* Individuals between the ages of 55 and 89 years old
* Meeting criteria for Mild Cognitive Impairment or dementia with a minimum MOST score of 5 but not over 23
* Has a minimum of 3 months evaluation
* Able to undergo testing for cognition and complete the GDS

Exclusion Criteria:

* Known allergy/intolerance to any ingredient in Cerefolin NAC®
* Substantial impediments to adherence, such as severe dementia without caregiver to administer medication
* Inability to swallow pill-form medication
* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
* Hcy score lower than 11

Primary outcomes:
measure: Change from Baseline in Levels of Homocysteine Over Time
timeFrame: Week 6, Week 12, and Quaterly Thereafter @ 6 Month Intervals
Secondary outcomes:
measure: To evaluate the safety and tolerability of Cerefolin NAC® based on adverse events, discontinuation due to intolerability and compliance.
timeFrame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals
measure: 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.
timeFrame: Baseline, Week 6, Week 12, and Quarterly Thereafter @ 6 Month Intervals
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Clionsky Neuro Systems, Inc.
state: Massachusetts
Study officials:
affiliation: Clionsky Neuro Systems Inc.
name: Emily Clionsky, MD
role: PRINCIPAL_INVESTIGATOR
References: