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Risk/benefit ratio did not indicate further study would be useful, or fair to future subjects.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memory XL | Experimental | 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. |
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| placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memory XL | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 months |
| 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. | baseline before intervention to 12 months of intervention |
| 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. | baseline to 12 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marilee Monnot, Ph.D. | University of Oklahoma HSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. of Okla. Health Sciences Center & VAMC OKC | Oklahoma City | Oklahoma | 73104 | United States | ||
| Veterans Affairs Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Chan, A., Paskavitz, J., Remington, J.R., Rasmussen, S., Shea, T.B. (2009). |
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Over 1.5 yrs, only 19 of 533 memory clinic patients were diagnosed with Mild Cognitive Impairment and who met inclusion/exclusion criteria. Most of the MCI patients had serious medical problems that affected cognition. Ten subjects agreed to be in this study.
Patients diagnosed with Mild Cognitive Impairment (MCI) in VA and OU campus clinics were given opportunity to participate in the trial, if they met inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nutriceutical (MemoryXL) Effects on Cognition & Behavior | Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study. |
| FG001 | Placebo Effects on Cognition/Behavior | Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nutriceutical (MemoryXL) Effects on Cognition & Behavior | Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Subjects diagnosed as Mild Cognitive Impairment (MCI) in VA clinic were given opportunity to participate in the study if they met inclusion/exclusion criteria (no illnesses that cause brain damage or are uncontrolled such as brittle diabetes). | Posted | Number | participants | 12 months |
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12-month study (double-blind) of Mild Cognitive Impairment patients recruited from VAMC Neurosciences memory loss clinic.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nutriceutical (MemoryXL) Effects on Cognition & Behavior | Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study. |
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Benefits of study did not appear to outweigh subject inconvenience, so study was stopped prematurely. Also, very few 'healthy' MCI subjects were recruited from the clinic population; vast majority of MCI patients had exclusionary medical problems.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marilee Monnot, PhD | UOklahoma Health Sciences Center | 405-456-5773 | 5773 | marilee-monnot@ouhsc.edu |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| placebo | Drug | placebo comparator |
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| baseline to 12 months |
| 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. | baseline to 12 months |
| 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. | baseline to 12 months |
| 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). | baseline to 12 months |
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |
| BG001 | Placebo Effects on Cognition/Behavior | Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Dementia Rating Scale | Dementia Rating Scale (DRS) = cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels. Higher scores mean more competence (range = 0 to 180 points). | Mean | Standard Deviation | total raw score points for 5 domains |
|
| MiniMental State Exam (MMSE) | MiniMental State Exam (MMSE) is a cognitive screening device with possible 30 points; higher scores mean more competence, and scores can range from 0-30 points. | Mean | Standard Deviation | total 1st MMSE score parameters |
|
| Neuropsychiatric Inventory NPI) | Neuropsychiatric Inventory (NPI) behavior rating scale includes 12 domains; higher numbers mean more psychiatric pathology (0 to 36 points). | Mean | Standard Deviation | total raw scores by group |
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| Modified Clinical Dementia Rating scale (CDR) | Modified CDR is a behavior rating scale of 8 domains, with 5 incremental scores for each domain (0, 0.5, 1, 2, 3). Total raw score of 0 means patient is healthy; raw score of 1 to <8 points from the 8 domains earns subject a CDR scale score of 0.5 (Mild Cognitive Impairment, no dementia). Total scaled score of 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia. | Mean | Standard Deviation | total raw scores by study group |
|
| Activities of Daily Living (ADL) | ADL is a behavior rating scale with 6 domains of self-care (feeding, toileting, etc.), with 3 incremental scores (1, 2, 3) in which higher scores mean more pathology (total scores of 6 to 18 points). | Mean | Standard Deviation | total initial raw scores by group |
|
| Instrumental Activities of Daily Living (IADL) | IADL is a behavior rating scale with 9 domains, and 3 incremental scores ( 1, 2, 3). Total scores can range from 9 to 27, with higher scores indicating more pathology. | Mean | Standard Deviation | total initial scores by study group |
|
| Clock Drawing Test | Clock Drawing Test is a cognitive screening instrument in which subjects are asked to draw a traditional clock and place the hands at a specified time. Scoring in this version used 8 indicators of accuracy and skill, with higher scores showing more competence (0-8 pts possible). | Mean | Standard Deviation | initial total raw score by group |
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| OG001 | Placebo Arm | Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills. |
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| Primary | 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. | All participants who completed 12-month study were included in the ANOVA analysis of the differences in scores of tests between baseline and end assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
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| Primary | 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. | All subjects who completed the 12-month study were included (placebo and nutriceutical arms/groups). | Posted | Mean | Standard Error | units on a scale | baseline before intervention to 12 months of intervention |
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| Primary | 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. | All subjects who completed the 12-month study were included. | Posted | Mean | Standard Error | units on a scale | baseline to 12 months |
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| Primary | 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. | All subjects who completed the 12-month study were included. | Posted | Mean | Standard Error | units on a scale | baseline to 12 months |
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| Primary | 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. | All subjects who completed 12-month study were included. | Posted | Mean | Standard Error | units on a scale | baseline to 12 months |
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| Primary | 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. | All subjects who completed 12-month study were included. | Posted | Mean | Standard Error | units on a scale | baseline to 12 months |
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| Primary | 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). | All subjects who completed 12-month study were included. | Posted | Mean | Standard Error | units on a scale | baseline to 12 months |
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| 8 |
| EG001 | Placebo Effects on Cognition/Behavior | Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label. | 0 | 2 | 0 | 2 |
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