Study of the Effects of Cerefolin NAC on Inflammation Blood Markers in Older Individuals With Memory Complaints

NCT00597376 | Completed Results

• 1 other identifier: Pamlab-Cerefolin NAC-001-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this six-month research study is to determine if Cerefolin NAC reduces levels of substances in the blood that may be associated with thinking ability and the health of brain cells in subjects with memory concerns when compared to a standard multivitamin. Cerefolin NAC is available as a dietary supplement via a prescription from a physician. The multivitamin used in the study contains the Recommended Daily Intake recommended for older persons.

Conditions

Subjective Memory Loss in Older Persons

Keywords

memory loss

Outcome Measures

Primary Outcomes (1)

• Six Month Blood Levels of Homocysteine, Glutathione, and the Ratio of Aβ42 to Aβ40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only

  Primary outcome markers were plasma homocysteine (tHcy), glutathione, and the ratio of amyloid proteins, Aβ42 and Aβ40. Plasma tHcy and glutathione were assayed using a high performance liquid chromatography (HPLC) with fluorescence detection method. Enzyme-linked immunosorbent assays (ELISA) were used for Aβ42 (Wako Chemicals USA, Inc., Richmond, VA) and Aβ40 (Invitrogen Corporation, Canarillo, CA) detection. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess the primary biomarker level at 6 months versus baseline. Six month levels in biomarker outcomes were compared using t-tests of the logarithmically transformed values and the antilogarithm was applied to the SDs obtain 95% confidence intervals (95% CIs). A significant difference between treatments was needed for at least one of the primary outcome variables (tHcy, glutathione, or the Aβ42 to Aβ40 ratio) to declare the study positive.

  6 months

Secondary Outcomes (2)

• Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only

  6 months

• Six Month Levels of Inflammation and Oxidative Stress Markers(as a Percent of Baseline Levels) After Daily Treatment With Cerefolin NAC and a Multivitamin or a Multivitamin Only

  6 months

Study Arms (2)

1

EXPERIMENTAL

On Cerefolin NAC and open-label multivitamin supplement

Other: Cerefolin NAC (a medical food)

2

PLACEBO COMPARATOR

On placebo and open label multivitamin supplement

Other: Cerefolin NAC placebo

Interventions

Cerefolin NAC (a medical food) OTHER

Cerefolin NAC one tablet each day

1

Cerefolin NAC placebo OTHER

Placebo tablet once a day

2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 60;
• Memory complaints as defined by two questions:
• "Do The subject think your have memory problems?"; and,
• "Has there been a decline in your memory over the last 10 years?"
• Fluency in English;
• Ability to ingest oral medications; and,
• Willing to replace current vitamin intake with a standardized multivitamin provided for the study.

You may not qualify if:

• Clinical stroke or Parkinson's disease;
• Taking FDA approved drug for symptomatic treatment of Alzheimer's disease (Aricept, Razadyne, Exelon, and/or Namenda);
• History of significant renal insufficiency (creatinine ≥1.5);
• History of renal stones or peptic ulcer disease;
• Use of vitamin supplements containing more than 400mcg of folic acid per day within 2 months of Screen Visit;
• As determined by the study physician, clinically significant serum folate and vitamin B12 deficiency on screening blood tests that would require further clinical evaluation and treatment
• As determined by the study physician, clinically significant medical conditions, physical exam findings or abnormal blood tests at screening that would require further clinical evaluation and treatment
• B12 injections 6 months prior to the Screen Visit;
• Confirmed clinical diagnosis of Mild Cognitive Impairment (MCI), vascular dementia or Alzheimer's Disease (AD); and,
• Known hypersensitivity to L-methylfolate, methyl-cobalamin or N-acetylcysteine.
• Use of any other investigational agent used during the 30 days prior to Screening.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Pamlab, Inc.: collaborator

Study Sites (1)

Rush Alzheimer's Disease Center

Chicago, Illinois, 60612, United States

Location

Related Links

• Rush Alzheimer's Disease Center

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No limitations or caveats to report.

Results Point of Contact

• Title: Raj C. Shah, MD
• Organization: Rush University Medical Center

Raj_C_Shah@rush.edu

312-563-2902

Study Officials

• Raj C Shah, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Family Medicine and Rush Alzheimer's Disease Center

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: November 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 23, 2013
• Results First Posted: May 23, 2013

Record last verified: 2013-05

Locations

US (1)