Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462228
Status:
TERMINATED
Last Update Posted:
2017-01-23
First Post:
2007-04-10
Brief Title:
Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
Double-blind Cross-over Study of the Effect of Namenda on Short Term Memory and Attention in Patients With Mild to Moderate Traumatic Brain Injury Protocol NAM-MD-44
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to a lack of additional subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether memantine Namenda improves memory and attention in patients with mild to moderate traumatic brain injury
Detailed Description:
Background and significance
Each year in the United States approximately 15 million people sustain a traumatic brain injury TBI and of these approximately 80-90000 result in long-term or lifelong disability An estimated 53 million people are currently living with a disability due to TBI The Centers for Disease Control CDC estimated that about 75 11 million of the reported TBIs are concussions or other forms of mild TBIs MTBI However the incidence of MTBI has been vastly underestimated according to a CDC Report to Congress
The long term problem associated with MTBI is primarily memory impairment Memory impairment resulting form MTBI is not likely to improve with time beyond the initial stabilizing period of about one year post-injury Dementia from Alzheimers Disease produces cognitive problems that are similar to those experienced by patients with mild to moderate traumatic brain injury The efficacy of Namenda for treatment of cognitive problems due to Alzheimers Dementia suggests it may have efficacy for treatment of short term memory and attention deficits in patients with mild to moderate traumatic brain injury
Overall Design and Plan of Study
Twenty post-TBI patients whose TBI occurred at least 1 year prior to beginning the study will be recruited for this pilot study Patients who meet screening criteria will have cognitive abilities assessed at baseline and at subsequent visits while taking Namenda or placebo Patients will be randomly assigned to begin either Namenda or placebo and will then crossover to the alternate treatment Each patient will participate in the study for a total of 32 to 34 weeks Patients completing the study will have 10 total visits and 6 visits at which a cognitive test battery will be administered This will include 24 weeks of study drug treatment 12 weeks of Namenda and 12 weeks of placebo and two 4-week washout periods Patients will be titrated up to 20 mg of Namenda per day Namenda and placebo will be provided by Forest Laboratories Inc
Cognitive screening criteria include a Galveston Orientation and Amnesia Test GOAT score of at least 75 and either a Mini-Mental State Exam MMSE score of 20 to 27 obtained at the screening visit or a California Verbal Learning Test CVLT total score for trials 1-5 one standard deviation lower than the age matched normative score The CVLT score for inclusion may be obtained from the medical record provided that the CVLT testing occurred one year or more post TBI and within two years of study entry
The cognitive test battery measurements will be made at the first baseline before Namenda or placebo administration week 0 and at weeks 6 12 after Namenda or placebo administration After washout for 4 weeks the second baseline week 16 will be assessed and the cognitive test battery will be administered again at weeks 22 28 after Namenda or placebo administration
The cognitive test battery used to assess efficacy will utilize the following tests
Verbal Memory Hopkins Verbal Learning Test Revised HVLT-R Visual Memory Brief VisuoSpatial Memory Test Revised BVMT-R Speed of processing Trail Making Test Part A Attention Trail Making Test Part B Memoryprocessing speed Symbol Digit Modality Test SDMT
The primary endpoints for cognitive assessment will be the HVLT-R and the BVMT-R The 6 different forms of the HVLT-R and BVMT-R will be administered at each of the 6 cognitive test battery assessments The sequence of forms administered will be randomized The other listed cognitive tests will be considered secondary endpoints An additional secondary efficacy endpoint will be the Physicians Global Impression of Change which will be recorded with the same visit frequency as other cognitive tests
In addition to the neuropsychological tests patients will have physical examinations electrocardiograms and laboratory tests of blood and urine Safety and tolerability will be monitored by clinical assessment reporting of adverse events and laboratory values Patient health will be assessed at clinic visits every 3-6 weeks throughout the study Serum pregnancy for females of child bearing potential will be completed at screening and at weeks 12 and 28 Urine pregnancy tests will be completed at baseline week 0 and weeks 16 32 A Safety Officer will be utilized as the primary means of monitoring safety of the study The Safety Officer will be a physician not associated with the study in any other capacity The Safety Officer will be given periodic reports of clinical assessments laboratory values and adverse events
Each year in the United States approximately 15 million people sustain a traumatic brain injury TBI and of these approximately 80-90000 result in long-term or lifelong disability An estimated 53 million people are currently living with a disability due to TBI The Centers for Disease Control CDC estimated that about 75 11 million of the reported TBIs are concussions or other forms of mild TBIs MTBI However the incidence of MTBI has been vastly underestimated according to a CDC Report to Congress
The long term problem associated with MTBI is primarily memory impairment Memory impairment resulting form MTBI is not likely to improve with time beyond the initial stabilizing period of about one year post-injury Dementia from Alzheimers Disease produces cognitive problems that are similar to those experienced by patients with mild to moderate traumatic brain injury The efficacy of Namenda for treatment of cognitive problems due to Alzheimers Dementia suggests it may have efficacy for treatment of short term memory and attention deficits in patients with mild to moderate traumatic brain injury
Overall Design and Plan of Study
Twenty post-TBI patients whose TBI occurred at least 1 year prior to beginning the study will be recruited for this pilot study Patients who meet screening criteria will have cognitive abilities assessed at baseline and at subsequent visits while taking Namenda or placebo Patients will be randomly assigned to begin either Namenda or placebo and will then crossover to the alternate treatment Each patient will participate in the study for a total of 32 to 34 weeks Patients completing the study will have 10 total visits and 6 visits at which a cognitive test battery will be administered This will include 24 weeks of study drug treatment 12 weeks of Namenda and 12 weeks of placebo and two 4-week washout periods Patients will be titrated up to 20 mg of Namenda per day Namenda and placebo will be provided by Forest Laboratories Inc
Cognitive screening criteria include a Galveston Orientation and Amnesia Test GOAT score of at least 75 and either a Mini-Mental State Exam MMSE score of 20 to 27 obtained at the screening visit or a California Verbal Learning Test CVLT total score for trials 1-5 one standard deviation lower than the age matched normative score The CVLT score for inclusion may be obtained from the medical record provided that the CVLT testing occurred one year or more post TBI and within two years of study entry
The cognitive test battery measurements will be made at the first baseline before Namenda or placebo administration week 0 and at weeks 6 12 after Namenda or placebo administration After washout for 4 weeks the second baseline week 16 will be assessed and the cognitive test battery will be administered again at weeks 22 28 after Namenda or placebo administration
The cognitive test battery used to assess efficacy will utilize the following tests
Verbal Memory Hopkins Verbal Learning Test Revised HVLT-R Visual Memory Brief VisuoSpatial Memory Test Revised BVMT-R Speed of processing Trail Making Test Part A Attention Trail Making Test Part B Memoryprocessing speed Symbol Digit Modality Test SDMT
The primary endpoints for cognitive assessment will be the HVLT-R and the BVMT-R The 6 different forms of the HVLT-R and BVMT-R will be administered at each of the 6 cognitive test battery assessments The sequence of forms administered will be randomized The other listed cognitive tests will be considered secondary endpoints An additional secondary efficacy endpoint will be the Physicians Global Impression of Change which will be recorded with the same visit frequency as other cognitive tests
In addition to the neuropsychological tests patients will have physical examinations electrocardiograms and laboratory tests of blood and urine Safety and tolerability will be monitored by clinical assessment reporting of adverse events and laboratory values Patient health will be assessed at clinic visits every 3-6 weeks throughout the study Serum pregnancy for females of child bearing potential will be completed at screening and at weeks 12 and 28 Urine pregnancy tests will be completed at baseline week 0 and weeks 16 32 A Safety Officer will be utilized as the primary means of monitoring safety of the study The Safety Officer will be a physician not associated with the study in any other capacity The Safety Officer will be given periodic reports of clinical assessments laboratory values and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None