MemoryXL Effects on Mild Cognitive Impairment Patients

This study has been terminated.
(Risk/benefit ratio did not indicate further study would be useful, or fair to future subjects.)
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00903695
First received: May 14, 2009
Last updated: January 25, 2012
Last verified: January 2012

May 14, 2009
January 25, 2012
June 2009
May 2011   (final data collection date for primary outcome measure)
  • Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.
  • Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group [ Time Frame: baseline before intervention to 12 months of intervention ] [ Designated as safety issue: No ]
    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.
  • Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    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.
  • Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    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.
  • Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    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.
  • Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    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.
  • Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    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).
All cognitive and behavioral test scores will remain constant or show improvement in subjects taking Memory XL. No subjects will show side effects or adverse affects that stop them from participation (in placebo or Memory XL arms). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00903695 on ClinicalTrials.gov Archive Site
Number of Subjects Who Converted to Early Alzheimer's (Dementia). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
No subjects will convert of early Alzheimer's disease while taking Memory XL, but at least 25% of subjects taking the placebo will convert to early stage AD. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
MemoryXL Effects on Mild Cognitive Impairment Patients
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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Mild Cognitive Impairment
  • Drug: 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
    Other Name: nutriceutical
  • Drug: placebo
    placebo comparator
  • 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.

    Intervention: Drug: Memory XL
  • 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.

    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00903695
14594
Yes
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Marilee Monnot, Ph.D. University of Oklahoma HSC
University of Oklahoma
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP