- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00903695
MemoryXL Effects on Mild Cognitive Impairment Patients (MemoryXL)
Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center
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Oklahoma City, Oklahoma, United States, 73104
- Univ. of Okla. Health Sciences Center & VAMC OKC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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 Names:
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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. |
placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 12 months
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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.
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baseline before intervention to 12 months of intervention
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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.
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baseline to 12 months
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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.
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baseline to 12 months
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Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group
Time Frame: baseline to 12 months
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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.
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baseline to 12 months
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Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group
Time Frame: baseline to 12 months
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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.
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baseline to 12 months
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Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group
Time Frame: baseline to 12 months
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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).
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baseline to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Who Converted to Early Alzheimer's (Dementia).
Time Frame: 12 months
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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.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marilee Monnot, Ph.D., University of Oklahoma HSC
Publications and helpful links
General Publications
- Chan, A., Paskavitz, J., Remington, J.R., Rasmussen, S., Shea, T.B. (2009).
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14594
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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