Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements

Last updated: April 27, 2015
Sponsor: Pamlab, Inc.
Overall Status: Completed

Phase

N/A

Condition

Memory Loss

Dementia

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT01745198
NAC-002c
  • Ages > 18
  • All Genders

Study Summary

In a retrospective analysis of data from 1100 patients, disease-delaying effects of Cerefolin®/CerefolinNAC® were examined in terms of cognition. The purpose of the current study is to expand the retrospective study dataset by prospectively collecting additional biomarker and imaging data.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • With a diagnosis of normal aging (NL), cognitive impairment or dementia not otherwisespecified (CI/D), or ADRD

  • With at least one previous quantitative MRI (qMRI)

  • With at least one previous homocysteine level

  • Without homocysteinemia plus no past or current B12, folate or Cerefolin® treatment,OR with homocysteinemia plus past or current Cerefolin® treatment

Exclusion

Exclusion Criteria: Subjects who do not meet the inclusion criteria will be excluded from the study.

Study Design

Total Participants: 121
Study Start date:
December 01, 2012
Estimated Completion Date:
June 30, 2014

Study Description

CerefolinNAC® is an orally administered prescription medical food, and is formulated as a combination of L-methylfolate calcium (as Metafolin®), methylcobalamin, and N-acetylcysteine. In a retrospective analysis, disease-delaying effects of Cerefolin®/CerefolinNAC® (CFLN) are examined in terms of cognition (measured by MCI Screen (MCIS)), and functional capacity (measured by Functional Assessment Staging Test (FAST)). - the treatment effect of CFLN on cognitive and functional measures, and on biomarker measures in patients with Alzheimer's disease and related disorders (ADRD).

The current study will expand the NAC-002b study dataset by prospectively collecting additional biomarker and imaging data in a more comprehensively assessed, matched sample of patients. This will allow more precise evaluation of cognitive and functional outcome measures, and biomarker measures will be assessed in an attempt to identify specific populations or conditions in which CFLN is most effective.

The sample will consist of patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group). Also 65 additional subjects will be recruited for the non-Treatment group, which will be used to improve the rate of decline estimates for the cognitive and functional outcome measures.

Connect with a study center

  • Hoag Memorial Hospital

    Newport Beach, California 92663
    United States

    Site Not Available

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