MemoryXL Effects on Mild Cognitive Impairment Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Mild Cognitive Impairment	Drug: Memory XL Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients

Resource links provided by NLM:

MedlinePlus related topics: Dementia Memory Mild Cognitive Impairment

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

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.

Enrollment:	10
Study Start Date:	June 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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
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.	Drug: placebo placebo comparator

Arms

Assigned Interventions

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.

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

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.

Drug: placebo

placebo comparator

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).

Eligibility

Ages Eligible for Study:	55 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903695

Locations

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

Sponsors and Collaborators

University of Oklahoma

Investigators

Principal Investigator:

Marilee Monnot, Ph.D.

University of Oklahoma HSC

More Information

No publications provided

Responsible Party:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00903695 History of Changes
Other Study ID Numbers:	14594
Study First Received:	May 14, 2009
Results First Received:	July 26, 2011
Last Updated:	January 25, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Oklahoma:

Memory XL
Mild Cognitive Impairment
cognitive status

Additional relevant MeSH terms:

Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013