MemoryXL Effects on Mild Cognitive Impairment Patients

NCT ID: NCT00903695

Last Updated: 2012-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-05-31

Brief Summary

A vitamin nutriceutical, Memory XL, has been shown to provide maintenance of cognitive status in mild, moderate, and severe Alzheimer's disease patients (2 publications by T. Shea). Because this nutriceutical is now patented by the Univ. of Mass., other trials at that institution may be considered a conflict of interest. Therefore, a study of its effects on Mild Cognitive Impairment (MCI) patients will be conducted by PI who is not affiliated with Univ. of Mass. or with Dr. Shea. The study hypothesis is: Memory XL will maintain or improve the cognitive and behavioral status of patients diagnosed with MCI during the year of participation in the study; normally, 10-25% of MCI patients convert to mild Alzheimer's dementia each year.

Detailed Description

This IRB-approved study is a randomized double blind study of patients diagnosed with Mild Cognitive Impairment (MCI) in the Center for Alzheimer's and Neurodegenerative Disorders (CANDO) at VAMC in Oklahoma City. Dr. Shea provided the pills (nutriceutical and placebos) from the same batches he used in former studies of Alzheimer's disease patients (produced by Nutricap Labs, Farmingdale, NY). Pills were dispensed by the OKC VAMC research pharmacist, using a random numbering system. The PI completed five cognitive testing sessions, lasting 1 to 1.5 hours, for each subject during the 12 months of participation in the study. Subject's spouse or family member completed 4 questionnaires about the subject's behavioral changes, and kept daily records of the times each day when the subject ingested the study pill assigned by the pharmacist. All subjects are patients in the VAMC memory loss clinic (CANDO) who are monitored by their neurologists (2 co-investigators in this study).

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Memory XL

Subjects will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D.).

Mild Cognitive Impairment (MCI) patients, who met inclusion/exclusion criteria, were assessed initially using 3 cognitive tests and 4 behavioral questionnaires, before they began ingesting pills assigned to them by VAMC Research Pharmacist. Each 3 months thereafter, they returned to lab to be reassessed using same instruments, and to receive the next batch of study pills from the Pharmacist. The last assessment was when the patient had just finished 12 months of pill ingestion.

Group Type: EXPERIMENTAL

Memory XL

Intervention Type: DRUG

An over-the-counter vitamin nutriceutical patented by Univ. of Mass. that contains folic acid 400 mg, Vit. B12 6 ug, alpha-tocopherol 30 IU, S-adenosyl methionine (SAM) 400 mg, N-acetyl cysteine (NAC) 600 mg, \& acetyl-L-carnitine (ALCAR) 500 mg; 2 pills per day for 12 months

placebo

Subjects diagnosed with MCI took two placebo pills daily for 12 months; these pills are formulated to look and taste the same as the nutriceutical being studied, Memory XL, so study was double-blind. Procedures for this arm are exactly the same as the MEMORY XL arm.

MCI subjects were assessed using 3 cognitive tests and 4 behavioral questionnaires, before they began ingesting the pills assigned to them by the Research Pharmacist at VAMC. Each 3 months thereafter, they returned to lab to be reassessed using the same instruments, and to receive next batch of study pills. Last assessment was when patient had completed 12 months of pill ingestion.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo comparator

Interventions

Memory XL

An over-the-counter vitamin nutriceutical patented by Univ. of Mass. that contains folic acid 400 mg, Vit. B12 6 ug, alpha-tocopherol 30 IU, S-adenosyl methionine (SAM) 400 mg, N-acetyl cysteine (NAC) 600 mg, \& acetyl-L-carnitine (ALCAR) 500 mg; 2 pills per day for 12 months

Intervention Type: DRUG

placebo

placebo comparator

Intervention Type: DRUG

Other Intervention Names

nutriceutical

Eligibility Criteria

Inclusion Criteria

• MCI patients diagnosed at the VAMC Center for Alzheimers and Neurodegenerative Disorder (CANDO).
• Clinical Dementia Rating (CDR) score of 0.5.
• fluent in English.
• able to ambulate to the outpatient clinic and research laboratory
• have sight and hearing levels sufficient to complete neuropsychological testing.
• free from bipolar disorder and terminal illnesses such as cancer.
• must live with a spouse or adult relative who will record nutriceutical ingestion daily.
• subjects will be consecutively diagnosed patients from all ethnic groups.

Exclusion Criteria

• patients from protected categories such as prisoners and pregnant women.
• any MCI subject who develops a life-threatening disease such as terminal cancer, stroke, brain trauma, debilitating heart attack, etc.
• indication of inability to make decisions regarding study participation.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marilee Monnot, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma HSC

Locations

Univ. of Okla. Health Sciences Center & VAMC OKC

Oklahoma City, Oklahoma, United States

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, United States

Countries

United States

References

Chan, A., Paskavitz, J., Remington, J.R., Rasmussen, S., Shea, T.B. (2009).

Reference Type: BACKGROUND

Other Identifiers

14594

Identifier Type: -

Identifier Source: org_study_id