Effect of Cerefolin®/CerefolinNAC® on Biomarker Measurements

NCT01745198 | Completed

• 1 other identifier: NAC-002c
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease; Alzheimer's Disease Related Disorders

Keywords

homocysteinemia; dementia; depression; vitamin B12; folate; mild cognitive impairment; alzheimer's; homocysteine

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• Change in rate of cognitive decline as measured by the MCI Screen

  Baseline to end of study (estimated average of 48 months)

• Change in rate of cognitive decline as measured by The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Drawings

  Baseline to end of study (estimated average of 48 months)

• Change in rate of cognitive decline as measured by Trails A & B

  Baseline to end of study (estimated average of 48 months)

• Rate of atrophy of hippocampal volume

  Baseline to end of study (estimated average of 48 months)

• Rate of atrophy in cortical volume

  Baseline to end of study (estimated average of 48 months)

Study Arms (2)

Treatment Group

This group consists of patients diagnosed with homocysteinemia who have been treated with Cerefolin®/CerefolinNAC® in the past or are currently being treated with Cerefolin®/CerefolinNAC®.

Non-Treatment Group

This group consists of patients not diagnosed with homocysteinemia who have no past or current treatment with Vitamin B12, Folate or Cerefolin®/CerefolinNAC®.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with homocysteinemia plus past/current CFLN treatment (Treatment Group) will be matched to those without homocysteinemia plus no past/current B12, folate or CFLN treatment (Non-Treatment Group).

You may qualify if:

• 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

Sponsors & Collaborators

• Pamlab, Inc.: lead
• The Shankle Clinic: collaborator
• Hoag Memorial Hospital Presbyterian: collaborator

Study Sites (1)

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A single blood draw for approximately 6-10 mL of blood will be performed for the total plasma homocysteine measurement and genetic studies.

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Homocysteinemia; Dementia; Depression

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Study Officials

• William R Shankle, MS, MD, FACP

  Shankle Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 10, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

US (1)