MemoryXL Effects on Mild Cognitive Impairment Patients (MemoryXL)
|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
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Drug: Memory XL Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
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.
- Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group [ Time Frame: Baseline and 12 months ]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 ]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 ]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 ]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 ]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 ]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 ]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).
- Number of Subjects Who Converted to Early Alzheimer's (Dementia). [ Time Frame: 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903695
|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|
|Principal Investigator:||Marilee Monnot, Ph.D.||University of Oklahoma HSC|