Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements

Mild Cognitive Impairment Clinical Trial

Official title:

Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements in Patients With Mild Cognitive Impairment, Alzheimer's Disease and Related Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745198
• Other study ID #: NAC-002c
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: April 27, 2015
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• With a diagnosis of normal aging (NL), cognitive impairment or dementia not otherwise specified (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 Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Alzheimer's Disease Related Disorders
• Cognition Disorders
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	Hoag Memorial Hospital	Newport Beach	California

Sponsors (3)

Lead Sponsor	Collaborator
Pamlab, Inc.	Hoag Memorial Hospital Presbyterian, The Shankle Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in rate of cognitive decline as measured by the Memory Performance Index (MPI)	Change in MPI over time will be calculated using multiple retrospective time points.	Baseline to end of study (estimated average of 48 months)	No
Secondary	Change in rate of cognitive decline as measured by the MCI Screen	Change in MCI Screen over time will be calculated using multiple retrospective time points.	Baseline to end of study (estimated average of 48 months)	No
Secondary	Change in rate of cognitive decline as measured by The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Drawings	Change in CERAD drawings over time will be evaluated using multiple retrospective time points	Baseline to end of study (estimated average of 48 months)	No
Secondary	Change in rate of cognitive decline as measured by Trails A & B	Change in Trails A & B over time will be assessed using multiple retrospective time points	Baseline to end of study (estimated average of 48 months)	No
Secondary	Rate of atrophy of hippocampal volume	Decrease in hippocampal volume over time will be assessed using volumetric MRI	Baseline to end of study (estimated average of 48 months)	No
Secondary	Rate of atrophy in cortical volume	Decrease in cortical volume over time will be assessed using volumetric MRI	Baseline to end of study (estimated average of 48 months)	No
Secondary	Rate of atrophy in ventricular volume	Decrease in ventricular volume over time will be assessed using volumetric MRI	Baseline to end of study (estimated average of 48 months)	No
Secondary	Change in rate of cognitive decline as measured by Functional Assessment Staging Test (FAST)	Change in FAST over time will be calculated using multiple retrospective time points.	Baseline to end of study (estimated average of 48 months)	No