Clinical trial NCT00903695: MemoryXL Effects on Mild Cognitive Impairment Patients
Official title: Nutriceutical Effects on Cognitive Status in Mild Cognitive Impairment Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Keywords: Memory XL
Mild Cognitive Impairment
cognitive status
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group
timeFrame: Baseline and 12 months
measure: Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group
timeFrame: baseline before intervention to 12 months of intervention
measure: Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group
timeFrame: baseline to 12 months
measure: Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group
timeFrame: baseline to 12 months
measure: Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group
timeFrame: baseline to 12 months
measure: Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group
timeFrame: baseline to 12 months
measure: Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Number of Subjects Who Converted to Early Alzheimer's (Dementia).
timeFrame: 12 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Univ. of Okla. Health Sciences Center & VAMC OKC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Veterans Affairs Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma HSC
name: Marilee Monnot, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan, A., Paskavitz, J., Remington, J.R., Rasmussen, S., Shea, T.B. (2009).