Back to resultsMemoryXL Effects on Mild Cognitive Impairment Patients (MemoryXL)
Primary Purpose
Mild Cognitive Impairment
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Memory XL
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Memory XL, Mild Cognitive Impairment, cognitive status
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.
Sites / Locations
- Univ. of Okla. Health Sciences Center & VAMC OKC
- Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Memory XL
placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group
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
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
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
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
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
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
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00903695
Brief Title
MemoryXL Effects on Mild Cognitive Impairment Patients
Acronym
MemoryXL
Official Title
Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Risk/benefit ratio did not indicate further study would be useful, or fair to future subjects.
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Memory XL, Mild Cognitive Impairment, cognitive status
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Memory XL
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Memory XL
Other Intervention Name(s)
nutriceutical
Intervention Description
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
Intervention Name(s)
placebo
Intervention Description
placebo comparator
Primary Outcome Measure Information:
Title
Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group
Description
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.
Time Frame
Baseline and 12 months
Title
Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group
Description
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.
Time Frame
baseline before intervention to 12 months of intervention
Title
Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group
Description
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.
Time Frame
baseline to 12 months
Title
Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group
Description
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.
Time Frame
baseline to 12 months
Title
Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group
Description
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.
Time Frame
baseline to 12 months
Title
Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group
Description
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.
Time Frame
baseline to 12 months
Title
Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group
Description
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).
Time Frame
baseline to 12 months
Secondary Outcome Measure Information:
Title
Number of Subjects Who Converted to Early Alzheimer's (Dementia).
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilee Monnot, Ph.D.
Organizational Affiliation
University of Oklahoma HSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ. of Okla. Health Sciences Center & VAMC OKC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Chan, A., Paskavitz, J., Remington, J.R., Rasmussen, S., Shea, T.B. (2009).
Results Reference
background
Learn more about this trial
MemoryXL Effects on Mild Cognitive Impairment Patients
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