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July 26, 2001
A large, US-based clinical trial of an investigational drug in the treatment of cognitive impairment in MS is now underway and actively recruiting study subjects. The drug being studied is currently approved only for the treatment of mild to moderate dementia of the Alzheimer’s type.
Approximately 240 men and women with
all forms of multiple sclerosis, and with associated memory impairment,
are being sought to participate in the trial, which will take place at
about 20 clinical centers.
Participants will receive daily oral medication or inactive placebo for 12 weeks. Subjects will have a 50/50 chance of receiving medication or placebo during the study.
The primary outcome to be evaluated is impact of treatment on memory and other cognitive functions as well as safety and tolerability.
For a listing of participating centers
which can provide more information on the study, the drug, and the sponsor,
individuals may call 1-866-812-8547.
A large clinical trial involving multiple centers in the United States is now underway to test the ability of an investigational drug to treat cognitive impairment in multiple sclerosis, and is actively recruiting study subjects. The drug being studied is currently approved only for the treatment of mild to moderate dementia of the Alzheimer’s type. For regulatory reasons, the name of the drug and sponsor have not been released.
While the cognitive problems in MS, most commonly problems with learning, memory and the speed of processing information are not equivalent to the dementia seen in Alzheimer’s disease, this study will investigate whether a drug shown to improve cognition in Alzheimer’s disease will improve cognition in MS.
About 20 U.S. clinical centers will enroll 240 men and women between the ages of 25 and 60 with all types of MS, who have significant memory impairment. To complete the comprehensive neuropsychological and cognitive tests involved in the study, all subjects must be fluent in English, and a caregiver or family member must be available to accompany the participant on four of the study visits.
Individuals using available disease-modifying drugs for MS (interferons, glatiramer acetate) are eligible to participate. Individuals with other neurological disorders, such as Parkinson’s or Alzheimer’s disease, are not eligible, nor are those with a history of learning disabilities or cognitive problems that preceded their MS diagnosis. Subjects must be free of seizures, drug or alcohol abuse, unstable diabetes, uncontrolled hypertension, and uncontrolled depression. Other than MS, patients must be healthy and medically stable. Women of childbearing potential must have a negative serum pregnancy test. An MRI scan (a picture of the brain) will also be performed at screening if one has not been done in the previous six months.
After screening to ascertain eligibility for the trial, individuals in the study will be randomly assigned to once-daily oral treatment with medication (120 subjects) or inactive placebo (120 subjects), meaning that participants will have a 50/50 chance of receiving medication or placebo during the study. Treatment will continue for each participant for 12 weeks. Safety and clinical assessments will be conducted at clinical visits every three weeks during the trial, for a total of four visits once treatment begins. Study participants, as well as clinic personnel, will be “blinded” as to which treatment each individual is taking.
Treatment effects will be evaluated based on differences between the treated and placebo subjects on a variety of memory and other cognitive and neuropsychological tests and scales. Procedures to evaluate safety include blood tests, electrocardiograms (a tracing of the electrical activity of the heart), physical exams and vital signs.
Centers participating in the study are actively enrolling subjects. If you are interested in participating in this research study, please call the following number for a list of participating sites: 1-866-812-8547.