Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071721
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2003-10-29
Brief Title:
Valproate in Dementia VALID
Sponsor:
Alzheimers Disease Cooperative Study ADCS
Organization:
Alzheimers Disease Cooperative Study ADCS
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial of Valproate to Attenuate the Progression of Alzheimers Disease AD
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 trial is to demonstrate whether valproate therapy delays the emergence of agitation andor psychosis in outpatients with probable Alzheimers disease AD who have not experienced agitation and psychosis in their illness A secondary aim is to determine whether valproate therapy delays the progression of cognitive and functional measures of the illness This trial will also assess the tolerability and safety of low-dose long-term valproate therapy Valproate an anticonvulsant drug was selected because of its possible symptomatic efficacy for agitation in AD known safety profile in numerous clinical populations and in view of recent data supporting its neuroprotective potential in AD
Detailed Description:
This study represents a novel clinical trial strategy designed to assess both prospective prophylactic therapy for psychopathology in Alzheimers disease AD and to assess an approach that may alter several aspects of the pathophysiology of AD and perhaps result in alteration of clinical progression of illness Interpretation of these results will be supported by study of relevant biomarkers and imaging data Valproate was selected because of its possible symptomatic efficacy for agitation in AD known safety profile in numerous clinical populations and in view of recent data supporting its neuroprotective potential in AD The primary hypothesis is that chronic valproate administration to participants with AD who lack agitation and psychosis at baseline will delay the emergence of agitation andor psychosis An effect of this nature may have significant public health implications for instance by delaying institutionalization
This is a randomized placebo-controlled double blind multicenter 26-month trial of valproate therapy at a target dose of 10-12 mgkgday in 300 outpatients with mild to moderate Alzheimers Disease AD who lack agitation and psychosis at baseline and since onset of illness Participants will have regular clinic visits as well as telephone contacts for assessment of behavior cognition function safety and tolerability The chief secondary aim is to determine whether valproate administration to participants with AD will attenuate clinical progression of illness measured by a reduced rate of cognitive or functional decline In addition issues related to safety and tolerability with low-dose 10-12 mgkgday therapy will be addressed Biological specimens will be obtained to study markers selected for their relevance to the disease as well as the postulated mechanism of action of the valproate therapy Magnetic resonance imaging MRI scans will be performed prior to experimental treatment and after one year in a subset of participants in order to address possible drug-placebo differences in brain volume measures
Approximately 300 participants from 25-35 clinical trial centers in the United States will be enrolled Participation will include men and women with a diagnosis of probable Alzheimers disease age 55 or older weighing at least 40 kg 882 lbs residing in the community at baseline Mini Mental State Examination MMSE 10-20 inclusive who have not experienced agitation or psychosis since the onset of their illness and who do not require treatment with psychotropic medications with the exception of antidepressants used only for treatment of depressive symptoms and limited use of sedatives for sleep Participants their relatives guardians or authorized representatives and informants will be given ample opportunity to inquire about details of the study Informed consent forms covering consent for the trial itself as well as the genetic research and biological sample storage and MRI scans will be provided to protect the patients rights and confidentiality
This is a randomized placebo-controlled double blind multicenter 26-month trial of valproate therapy at a target dose of 10-12 mgkgday in 300 outpatients with mild to moderate Alzheimers Disease AD who lack agitation and psychosis at baseline and since onset of illness Participants will have regular clinic visits as well as telephone contacts for assessment of behavior cognition function safety and tolerability The chief secondary aim is to determine whether valproate administration to participants with AD will attenuate clinical progression of illness measured by a reduced rate of cognitive or functional decline In addition issues related to safety and tolerability with low-dose 10-12 mgkgday therapy will be addressed Biological specimens will be obtained to study markers selected for their relevance to the disease as well as the postulated mechanism of action of the valproate therapy Magnetic resonance imaging MRI scans will be performed prior to experimental treatment and after one year in a subset of participants in order to address possible drug-placebo differences in brain volume measures
Approximately 300 participants from 25-35 clinical trial centers in the United States will be enrolled Participation will include men and women with a diagnosis of probable Alzheimers disease age 55 or older weighing at least 40 kg 882 lbs residing in the community at baseline Mini Mental State Examination MMSE 10-20 inclusive who have not experienced agitation or psychosis since the onset of their illness and who do not require treatment with psychotropic medications with the exception of antidepressants used only for treatment of depressive symptoms and limited use of sedatives for sleep Participants their relatives guardians or authorized representatives and informants will be given ample opportunity to inquire about details of the study Informed consent forms covering consent for the trial itself as well as the genetic research and biological sample storage and MRI scans will be provided to protect the patients rights and confidentiality
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ADCS Protocol ADC-022-VN | US NIH GrantContract | None | httpsreporternihgovquickSearch1RC2AG036535 |
| 1RC2AG036535 | NIH | None | None |
| IND 67222 | None | None | None |