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MemoryXL Effects on Mild Cognitive Impairment Patients (MemoryXL)

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ClinicalTrials.gov Identifier: NCT00903695
Recruitment Status : Terminated (Risk/benefit ratio did not indicate further study would be useful, or fair to future subjects.)
First Posted : May 18, 2009
Results First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Mild Cognitive Impairment
Interventions Drug: Memory XL
Drug: placebo
Enrollment 10
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Nutriceutical (MemoryXL) Effects on Cognition & Behavior Placebo Effects on Cognition/Behavior
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 8 2
Completed 6 2
Not Completed 2 0
Reason Not Completed
medical exclusion after 1st testing             1             0
lung cancer             1             0
Arm/Group Title Nutriceutical (MemoryXL) Effects on Cognition & Behavior Placebo Effects on Cognition/Behavior Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 8 2 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  12.5%
0
   0.0%
1
  10.0%
>=65 years
7
  87.5%
2
 100.0%
9
  90.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 10 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
2
 100.0%
10
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 2 participants 10 participants
8 2 10
Dementia Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Total raw score points for 5 domains
Number Analyzed 8 participants 2 participants 10 participants
130  (2.3) 140  (4.7) 132  (7.5)
[1]
Measure Description: 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).
MiniMental State Exam (MMSE)   [1] 
Mean (Standard Deviation)
Unit of measure:  Total 1st MMSE score parameters
Number Analyzed 8 participants 2 participants 10 participants
27.5  (0.8) 28.5  (1.5) 27.7  (2.1)
[1]
Measure Description: 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.
Neuropsychiatric Inventory NPI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Total raw scores by group
Number Analyzed 8 participants 2 participants 10 participants
3.6  (1.3) 3.0  (2.6) 3.5  (3.4)
[1]
Measure Description: Neuropsychiatric Inventory (NPI) behavior rating scale includes 12 domains; higher numbers mean more psychiatric pathology (0 to 36 points).
Modified Clinical Dementia Rating scale (CDR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Total raw scores by study group
Number Analyzed 8 participants 2 participants 10 participants
5.6  (1.4) 6.5  (2.8) 5.8  (3.8)
[1]
Measure Description: 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.
Activities of Daily Living (ADL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Total initial raw scores by group
Number Analyzed 8 participants 2 participants 10 participants
6.3  (0.4) 8.0  (0.7) 6.6  (1.2)
[1]
Measure Description: 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).
Instrumental Activities of Daily Living (IADL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Total initial scores by study group
Number Analyzed 8 participants 2 participants 10 participants
14.2  (1.8) 13.0  (3.7) 14.0  (4.9)
[1]
Measure Description: 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.
Clock Drawing Test   [1] 
Mean (Standard Deviation)
Unit of measure:  Initial total raw score by group
Number Analyzed 8 participants 2 participants 10 participants
6.7  (0.3) 7.0  (0.7) 6.8  (0.9)
[1]
Measure Description: 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).
1.Primary Outcome
Title Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nutriceutical (MemoryXL) Effects on Cognition & Behavior Placebo Effects on Cognition/Behavior
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 6 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (3.0) -2.5  (5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nutriceutical (MemoryXL) Effects on Cognition & Behavior, Placebo Effects on Cognition/Behavior
Comments ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8133
Comments a priori threshold for statistical significance = 0.01 (multiple comparisons)
Method ANOVA
Comments

DF = 6

ANOVA calculation: F-ratio = 0.06, t-test = -0.25.

2.Primary Outcome
Title Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the 12-month study were included (placebo and nutriceutical arms/groups).
Arm/Group Title Nutriceutical Arm Placebo Arm
Hide Arm/Group Description:
Subjects who were assigned by VA research pharmacist to receive nutriceutical 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.
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.
Overall Number of Participants Analyzed 6 2
Mean (Standard Error)
Unit of Measure: units on a scale
-1.7  (1.6) 2.0  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nutriceutical Arm, Placebo Arm
Comments ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments a priori threshold for statistical sginficance = 0.01 (multiple comparisons)
Method ANOVA
Comments

DF = 6

ANOVA calculation: F-ratio=1.22, t-test=1.1

3.Primary Outcome
Title Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the 12-month study were included.
Arm/Group Title Nutriceutical Arm Placebo Arm
Hide Arm/Group Description:
Subjects who were assigned by VA research pharmacist to receive nutriceutical 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.
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.
Overall Number of Participants Analyzed 6 2
Mean (Standard Error)
Unit of Measure: units on a scale
0.5  (0.6) -1.0  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nutriceutical Arm, Placebo Arm
Comments ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments a priori threshold for statistical significance = 0.01 (multiple comparisons)
Method ANOVA
Comments

DF = 6

ANOVA: F-ratio = 1.5, t-test = -1.23

4.Primary Outcome
Title Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the 12-month study were included.
Arm/Group Title Nutriceutical Arm Placebo Arm
Hide Arm/Group Description:
Subjects who were assigned by VA research pharmacist to receive nutriceutical 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.
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.
Overall Number of Participants Analyzed 6 2
Mean (Standard Error)
Unit of Measure: units on a scale
-0.33  (0.5) 1.0  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nutriceutical Arm, Placebo Arm
Comments ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments a priori threshold for statistical significance = 0.01 (multiple comparisons)
Method ANOVA
Comments

DF = 6

ANOVA: F-ratio = 1.7, t-test = 1.3

5.Primary Outcome
Title Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed 12-month study were included.
Arm/Group Title Nutriceutical Arm Placebo Arm
Hide Arm/Group Description:
Subjects who were assigned by VA research pharmacist to receive nutriceutical 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.
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.
Overall Number of Participants Analyzed 6 2
Mean (Standard Error)
Unit of Measure: units on a scale
-4.0  (1.9) -2.5  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nutriceutical Arm, Placebo Arm
Comments ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments a priori threshold for statistical significance = 0.01 (multiple comparisons)
Method ANOVA
Comments

DF = 6

ANOVA: F-ratio = 0.15, t-test = 0.39

6.Primary Outcome
Title Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed 12-month study were included.
Arm/Group Title Nutriceutical Arm Placebo Arm
Hide Arm/Group Description:
Subjects who were assigned by VA research pharmacist to receive nutriceutical 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.
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.
Overall Number of Participants Analyzed 6 2
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.3) -1.0  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nutriceutical Arm, Placebo Arm
Comments ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments a priori threshold for statistical significance = 0.01 (multiple comparisons)
Method ANOVA
Comments

DF = 6

ANOVA: F-ratio = 2.25, ttest = -1.5

7.Primary Outcome
Title Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed 12-month study were included.
Arm/Group Title Nutriceutical Arm Placebo Arm
Hide Arm/Group Description:
Subjects who were assigned by VA research pharmacist to receive nutriceutical 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.
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.
Overall Number of Participants Analyzed 6 2
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (1.0) -2.0  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nutriceutical Arm, Placebo Arm
Comments ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments a priori threshold for statistical significance = 0.01 (multiple comparisons)
Method ANOVA
Comments

DF = 6

ANOVA: F-ratio = 1.06, t-test = -1.03

8.Secondary Outcome
Title Number of Subjects Who Converted to Early Alzheimer's (Dementia).
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Nutriceutical Arm Placebo Arm
Hide Arm/Group Description:
Subjects who were assigned by VA research pharmacist to receive nutriceutical 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.
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.
Overall Number of Participants Analyzed 6 2
Measure Type: Number
Unit of Measure: participants
0 1
Time Frame 12-month study (double-blind) of Mild Cognitive Impairment patients recruited from VAMC Neurosciences memory loss clinic.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nutriceutical (MemoryXL) Effects on Cognition & Behavior Placebo Effects on Cognition/Behavior
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Nutriceutical (MemoryXL) Effects on Cognition & Behavior Placebo Effects on Cognition/Behavior
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nutriceutical (MemoryXL) Effects on Cognition & Behavior Placebo Effects on Cognition/Behavior
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nutriceutical (MemoryXL) Effects on Cognition & Behavior Placebo Effects on Cognition/Behavior
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/2 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Marilee Monnot, PhD
Organization: UOklahoma Health Sciences Center
Phone: 405-456-5773 ext 5773
Publications:
Chan, A., Paskavitz, J., Remington, J.R., Rasmussen, S., Shea, T.B. (2009).
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00903695     History of Changes
Other Study ID Numbers: 14594
First Submitted: May 14, 2009
First Posted: May 18, 2009
Results First Submitted: July 26, 2011
Results First Posted: January 26, 2012
Last Update Posted: January 26, 2012