MemoryXL Effects on Mild Cognitive Impairment Patients (MemoryXL)

January 25, 2012 updated by: University of Oklahoma

Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients

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.

Study Overview

Status

Terminated

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Veterans Affairs Medical Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Univ. of Okla. Health Sciences Center & VAMC OKC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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
Other Names:
  • nutriceutical
Placebo Comparator: 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.

placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group
Time Frame: Baseline and 12 months
Dementia Rating Scale (DRS) is a cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels, so individuals can be compared. Higher scores mean more competence (0-36 points converted to percentiles so different ages can be compared). Total raw scores for the 5 domains were computed so that Mean and SD of differences between first and last assessments for all subjects, by study arms (nutriceutical = XL and placebo = PL) are reported here.
Baseline and 12 months
Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group
Time Frame: baseline before intervention to 12 months of intervention
CDR is a rating scale for 8 aspects of behavior with 0-3 points allowed; higher scores indicate more pathology. Total minimum and maximum scores are 0 and 36 respectively.Clinician rates the patient's behavior and competence with input from family members who live with the patient. ANOVA of differences between baseline and end scores of the CDR scale are reported here, by the study arm/group.
baseline before intervention to 12 months of intervention
Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group
Time Frame: baseline to 12 months
Clock Drawing Test is a cognitive screening instrument in which subjects are to draw a clock and set a specified time. Various scoring methods can be employed using 4 to 15 points, with more points showing more competence. This study used the 8-point scoring method, so that 0-8 points could be assigned during each of the baseline and 4 assessment periods during the 12-month study. ANOVA of the differences between baseline and end scores, by study arm/group was completed.
baseline to 12 months
Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group
Time Frame: baseline to 12 months
MiniMental State Exam is a cognitive screening device with possible 30 points in several categories; higher points indicate greater competence. Clinician tests orientation, attention, language, & visuo-spatial construction. Outcome measure is results of an ANOVA of differences between baseline and end/last scores, by study arm/group was completed.
baseline to 12 months
Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group
Time Frame: baseline to 12 months
NPI is a behavior rating scale with 12 categories in which a maximum score of 36 points indicates more pathology than a minimum score of 0. Outcome measure reported here is results of an ANOVA of the differences between baseline and end scores, by study arm/group, to detect any statistically significant difference (nutriceutical vs placebo groups) was completed.
baseline to 12 months
Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group
Time Frame: baseline to 12 months
ADL is a behavior rating scale with 6 domains of self-care (feeding, toileting, etc.) in which a maximum score of 18 indicates less competence than a minimum score of 6 (normal skills). Outcome measure is results of ANOVA of the differences between baseline and last/end scores, by study arm/group, to detect any statistically significant differences.
baseline to 12 months
Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group
Time Frame: baseline to 12 months
IADL is a behavior rating scale using 9 domains of household and community activities, with a total score of 27 points indicating less competence than a normal function score of 9 points. Outcome measure is results of an ANOVA of the differences between baseline and end/last score, by study arm/group, to detect statistically significant differences (nutriceutical vs placebo).
baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Converted to Early Alzheimer's (Dementia).
Time Frame: 12 months
Neurological diagnosis is based on test scores that reach -1.6 SD of mean for age/education, and on radiological tests of brain structure (CT, MRI, PET). Usual cutoff for test score percentile is <0.05 to diagnose dementia.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marilee Monnot, Ph.D., University of Oklahoma HSC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 14, 2009

First Submitted That Met QC Criteria

May 15, 2009

First Posted (Estimate)

May 18, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2012

Last Update Submitted That Met QC Criteria

January 25, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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