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Home > "V" Clinical Trials Conditions > Valproate in Dementia (VALID)  Valproate in Dementia (VALID)
Valproate in Dementia (VALID)
For Condition: Alzheimer Disease
Status: Recruiting
Sponsor(s): National Institute on Aging (NIA) , Alzheimer's Disease Research Center, University of California, San Diego
Synopsis: The purpose of this trial is to demonstrate whether valproate therapy delays the emergence of agitation and/or psychosis in outpatients with probable Alzheimer’s 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 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.
Details: This study represents a novel clinical trial strategy designed to assess both prospective "prophylactic" therapy for psychopathology in Alzheimer's disease (AD) and to assess an approach that may alter several aspects of the pathophysiology of AD, and perhaps resulting in alteration of clinical progression of illness. Intrepretation 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 and/or 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 mg/kg/day in 300 outpatients with mild to moderate Alzheimer's 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 mg/kg/day) 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. 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 Alzheimer’s disease, age 55 or older, weighing at least 40 kg (88.2 lbs.), residing in the community at baseline, 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 patient's rights and confidentiality.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 55 Years/90 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Probable AD by NINDS-ADRDA criteria. - Male or female. - > 55 and < 90 years of age. - Weight > 40 kg (88.2 lbs.). - Residing in the community at screen and baseline. Participants may reside in assisted living facilities, but not in long-term care nursing facilities or assisted living facilities that provide intensive support for people with dementia nor may they reside in a secure unit necessary for behavioral management. - Mini Mental State Examination at screen and baseline 12-20 inclusive. - CT or MRI since onset of dementia consistent with the diagnosis of probable AD. Single lacunes in non-critical areas non-specific white matter changes that are interpreted as age-related are not grounds for exclusion. Any ambiguous scan results must be reviewed with the Project Director. - Fluent in English or Spanish. - Supervision available for study medication. - Study partner to accompany subject to all visits. - Study partner must have in-person contact with the participant > 2 days/week. - Able to ingest oral medication. - Total NPI score for previous 4 weeks < 8 at Screening, and for the period between Screening and Baseline. - NPI item score for the items assessing delusions, hallucinations, agitation/aggression all greater than or equal to 1 for 4 weeks prior to Screening (less than once/week and mild severity at most) and for the period between Screening and Baseline. - Scores of greater than or equal to 1 for items rating delusions, hallucinations, and agitation/aggression taken from the NPI, modified to assess these features since onset of illness. This will be derived from a second interview with the modified NPI. (Agitation/psychosis during episodes of delirium are not considered exclusionary.). Exclusion Criteria: exceptions to these criteria may be considered on a case- by-case basis at the discretion of the Project Director. - Non-AD dementia. - Female of child-bearing potential. - Residence in a long-term care facility or equivalent at baseline. - Presence or previous history of agitation or psychosis requiring active psychotropic medication since the illness began. - History of clinically significant stroke. - Current evidence or history in past two years of: focal brain lesion, head injury with loss of consciousness or DSM IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse. - Sensory impairment that would prevent subject from participating in or cooperating with the protocol. - Medical contraindications to study participation. - Use of another investigational agent within two months prior to screening. - Evidence of any significant clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational new drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality. - Clinical contraindication to the use of valproate (e.g., known hypersensitivity or allergic reactions, severe neutropenia, severe hepatic disease, or urea cycle disorder. A urea cycle disorder should be considered in patients with history of unexplained encephalopathy following protein meals, or family history of urea cycle disorder). - History of seizure within past 5 years prior to screening. - Platelet count < 100,000/mm 3. - International Normalized Ratio (INR) > 1.2 or Partial Thromboplastin Time (PTT) > 40 seconds. - Active neoplastic disease. Exceptions: skin tumors other than melanoma are not excluded; patients with stable prostate cancer may be included at the discretion of the Project Director; women who have been treated for breast cancer and have no metastases and whose survival is expected to exceed 2 years may be considered for inclusion on a case-by-case basis in consultation with the Project Director; patients with purely localized bladder wall cancers may be included at the discretion of the Project Director. Excluded Medications: - Use of psychotropics for treatment of agitation or psychosis. Antidepressants used in stable doses for 3 months prior to screening to treat depression or anxiety, but not agitation, will be permitted. Low dose sedatives for sleep but not agitation will be permitted. Cholinesterase inhibitors used in stable doses for at least 3 months prior to screening are permitted. - Regular use of narcotic analgesics within 3 months of screening. - Anti-parkinsonian medications (e.g. levodopa, selegiline, pergolide, bromocriptine, pramipexole) within 2 months of screening. - Use of drugs with significant central anticholinergic or antihistaminic effects (eg, benztropine, trihexyphhenidyl, dicyclomine, diphenhydramine, cyproheptadine, diphenoxylate, hydroxyzine, meclizine, perchlorperazine, promethazine) within 2 months of screening. - Use of other investigational drug studies within two months prior to screening. - Use of other anticonvulsants within 5 years prior to screening. - Use of zidovudine at any time. - Use of tricyclic antidepressants within 1 month prior to screening. - Regular use of high doses of salicylates at screening (> 1,300 mg/d). - Vitamin E > 2,100 IU/d within 1 month prior to screening. - Warfarin use is permitted when approved by the Project Director and INR and PTT criteria are met.
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
PierreTariot, Study Director, University of Rochester Medical Center, Departments of Psychiatry, Medicine, and Neurology, and the Center for Aging and Developmental Biology
University of Southern California *Recruiting*
Los Angeles, California, 90089-0191
United States
Recruiting Amber Watts 323-422-3715
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Francine Parfitt 904-953-7103
Southwestern Vermont Medical Center *Recruiting*
Bennington, Vermont, 05201
United States
Recruiting Christine Holland 802-447-1409
Premier Research Institute *Recruiting*
West Palm Beach, Florida, 33407
United States
Recruiting Cora Kessel 561-845-0500
Indiana University School of Medicine *Recruiting*
Indianapolis, Indiana, 46202-5120
United States
Recruiting Martha Mendez 317-278-9773
University of Michigan *Recruiting*
Ann Arbor, Michigan, 48109-0489
United States
Recruiting Joanne Lord 734-615-3041
Medical University of South Carolina *Recruiting*
North Charleston, South Carolina, 29406-6076
United States
Recruiting Natasha Perreault 843-740-1592
University of Texas Southwestern Medical Center *Recruiting*
Dallas, Texas, 75390-9070
United States
Recruiting Alice Cox 214-648-7458
Case Western Reserve University, University Hospitals of Cleveland *Recruiting*
Cleveland, Ohio, 44120
United States
Recruiting Elaine Ziol 216-844-6328
Wein Center, Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Peggy Roberts 305-674-2424
Psychiatric Consultants *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Rosemary Saunders 615-250-6738
New York University Medical Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Suzanne Blaisdell 212-263-5708
University of South Florida *Recruiting*
Tampa, Florida, 33617
United States
Recruiting Dorothy Baxter 813-974-4355
Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Evelyn Dominguez 212-305-2371
University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Jennifer Chase 215-349-5903
University of Rochester *Recruiting*
Rochester, New York, 14642
United States
Recruiting Connie Brand 585-760-6585
University of Nevada *Recruiting*
Las Vegas, Nevada, 89154-5084
United States
Recruiting Gail Vranesh 702-671-5079
St. Louis University *Recruiting*
St. Louis, Missouri, 63103
United States
Recruiting Christina Morefield 314-268-5385
VA Long Beach Medical Center *Not yet recruiting*
Long Beach, California, 90822
United States
Not yet recruiting
University of California, ADRC, San Diego *Recruiting*
La Jolla, California, 92093-0624
United States
Recruiting Karen Wetzel 858-622-5800
Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20057
United States
Recruiting Carolyn Ward 202-784-6671
Stanford University, VA Aging Clinical Research Center *Recruiting*
Stanford, California, 94304
United States
Recruiting Lisa Kinoshita 650-493-5000
Brown University, Memorial Hospital of Rhode Island *Recruiting*
Providence, Rhode Island, 02860
United States
Recruiting Esther Oden 401-793-8232
Syracuse VA Medical Center *Not yet recruiting*
Syracuse, New York, 13210
United States
Not yet recruiting
North East Ohio Health Services *Recruiting*
Beachwood, Ohio, 44122
United States
Recruiting Elisa Poggi 216-831-6466
University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Paula Damgaard 434-243-5420
Yale University School of Medicine *Recruiting*
New Haven, Connecticut, 06511
United States
Recruiting Martha MacAvoy 203-764-8100
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Catherine Platt 312-695-2343
University of California, Irvine *Recruiting*
Irvine, California, 92697-4540
United States
Recruiting Catherine McAdams-Ortiz 949-824-8726
University of California ADRC *Recruiting*
Los Angeles, California, 90095-1769
United States
Recruiting Kavita Shankar 310-206-3779
Emory University *Recruiting*
Atlanta, Georgia, 30329
United States
Recruiting Jane Lu 404-728-4784
Additional Information:
Study ID Numbers: IA0043; ADCS Protocol ADC-022-VN,IND 67,222
Study Start Date: October 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071721
Other Alzheimer Disease Studies:
1. ALADDIN Study
2. Study of Aripiprazole in the Treatment of Patients with Psychosis Associated with Dementia of the Alzheimer's Type
3. Electrophysiologic Measures of Treatment Response in Alzheimer Disease
4. COGNIShunt® System for Alzheimer's Disease
5. Serotonergic Pharmacotherapy for Agitation of Dementia
Related Studies:
Other Alzheimer Disease Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Valproate in Dementia (VALID)
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