Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368459
Status:
COMPLETED
Last Update Posted:
2015-04-02
First Post:
2006-08-22
Brief Title:
Raloxifene for Women With Alzheimers Disease
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Raloxifene in Women With AD Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2015-03
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:
This is a multisite pilot randomized trial of raloxifene or placebo for the treatment of women with Alzheimers disease
Detailed Description:
Raloxifene a selective estrogen receptor modulator has attracted attention as a potential treatment for Alzheimers disease in women but it has not been studied in this disorder
To assess feasibility of large-scale efficacy trials and to obtain an initial estimate of treatment effect study investigators plan to conduct a pilot randomized double blind placebo-controlled clinical trial of high-dose 120 mg daily raloxifene Eligible participants are postmenopausal women with late-onset Alzheimers disease of mild-to-moderate severity taking a stable dose of an approved cholinesterase inhibitor This pilot study is not designed to have power to detect significant modest between-group differences of the magnitude provided by current FDA-approved therapies
Study participants will be randomly allocated to oral raloxifene or identical placebo over a 12 month period Outcomes of interest will be obtained at 6 and 12 months The prespecified primary outcome is the change in the Alzheimers Disease Assessment Scale cognitive subscale ADAS-cog compared between groups at 12 months Prespecified secondary outcomes include measures of global severity Clinical Dementia Rating sum of boxes function Activities of Daily Living behavior Neuropsychiatric inventory and other neuropsychological measures Caregiver outcomes will be burden Zarit burden inventory and distress from the Neuropsychiatric inventory
To assess feasibility of large-scale efficacy trials and to obtain an initial estimate of treatment effect study investigators plan to conduct a pilot randomized double blind placebo-controlled clinical trial of high-dose 120 mg daily raloxifene Eligible participants are postmenopausal women with late-onset Alzheimers disease of mild-to-moderate severity taking a stable dose of an approved cholinesterase inhibitor This pilot study is not designed to have power to detect significant modest between-group differences of the magnitude provided by current FDA-approved therapies
Study participants will be randomly allocated to oral raloxifene or identical placebo over a 12 month period Outcomes of interest will be obtained at 6 and 12 months The prespecified primary outcome is the change in the Alzheimers Disease Assessment Scale cognitive subscale ADAS-cog compared between groups at 12 months Prespecified secondary outcomes include measures of global severity Clinical Dementia Rating sum of boxes function Activities of Daily Living behavior Neuropsychiatric inventory and other neuropsychological measures Caregiver outcomes will be burden Zarit burden inventory and distress from the Neuropsychiatric inventory
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