Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470418
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2007-05-04
Brief Title:
Development of NIC5-15 in the Treatment of Alzheimers Disease
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Development of NIC5-15 in the Treatment of Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2017-01
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 study is to evaluate the safety and efficacy of NIC5-15in the treatment of Alzheimers Disease
Detailed Description:
Recent epidemiologic evidence has suggested that diabetes mellitus significantly increases risk for the development of Alzheimers disease independent of vascular risk factors Moreover even patients who are simply insulin resistant without frank diabetes have been shown to share this elevated risk for the development of AD As insulins role as a neuromodulator in the brain has been revealed several potential mechanisms for the interaction of diabetes or insulin resistance with AD have been suggested such as decreased cortical glucose utilization particularly in the hippocampus and entorhinal cortex increased oxidative stress through the formation of advanced glycation end products increased Tau phosphorylation and neurofibrillary tangle formation and increased beta-amyloid aggregation through inhibition of insulin-degrading enzyme The future treatment of AD might involve pharmacologic and dietary manipulations of insulin and glucose regulation
NIC5-15 is a single small naturally occurring molecule Animal studies and some human trials have shown NIC5-15 to be safe and a potent insulin sensitizer at doses equivalent to 800-2000mg per day In preclinical studies at doses higher than those previously studied in clinical trials we found that NIC5-15 interferes with the accumulation of beta amyloid an important step in the development of Alzheimers pathology These data suggest that NIC5-15 may be a reasonable therapeutic agent for the treatment of Alzheimer Disease for two reasons
1 It is a -secretase inhibitor that is Notch-sparing
2 It is potentially an insulin-sensitizer
However critical safety and human efficacy studies must be conducted This application proposes to conduct these early critical human studies The goal of the studies contained in this proposal is to establish safety and efficacy of NIC5-15 for the treatment of AD The specific objectives of this study are to
Specific Objective 1 Conduct a multiple dose safety study of NIC5-15 to establish safety in the doses that appear to block amyloid accumulation These studies will characterize the safety profile pharmacokinetics and tolerability
Specific Objective 2 Conduct a double blind placebo controlled pilot efficacy study of NIC5-15 in patients with AD The goals of this study are to
A Demonstrate feasibility for a multi-site trial that will be used to guide the design of a future larger effort Demonstration of feasibility will include examination of accrual rate overall recruitment adherence to protocol compliance with medication and willingness to complete a randomized trial and lack of short term toxicity
B Collect preliminary evidence of efficacy in terms of cognitive and global measures as well as secondary efficacy outcomes of activities of daily living behavioral disturbances and AD biomarkers
NIC5-15 is a single small naturally occurring molecule Animal studies and some human trials have shown NIC5-15 to be safe and a potent insulin sensitizer at doses equivalent to 800-2000mg per day In preclinical studies at doses higher than those previously studied in clinical trials we found that NIC5-15 interferes with the accumulation of beta amyloid an important step in the development of Alzheimers pathology These data suggest that NIC5-15 may be a reasonable therapeutic agent for the treatment of Alzheimer Disease for two reasons
1 It is a -secretase inhibitor that is Notch-sparing
2 It is potentially an insulin-sensitizer
However critical safety and human efficacy studies must be conducted This application proposes to conduct these early critical human studies The goal of the studies contained in this proposal is to establish safety and efficacy of NIC5-15 for the treatment of AD The specific objectives of this study are to
Specific Objective 1 Conduct a multiple dose safety study of NIC5-15 to establish safety in the doses that appear to block amyloid accumulation These studies will characterize the safety profile pharmacokinetics and tolerability
Specific Objective 2 Conduct a double blind placebo controlled pilot efficacy study of NIC5-15 in patients with AD The goals of this study are to
A Demonstrate feasibility for a multi-site trial that will be used to guide the design of a future larger effort Demonstration of feasibility will include examination of accrual rate overall recruitment adherence to protocol compliance with medication and willingness to complete a randomized trial and lack of short term toxicity
B Collect preliminary evidence of efficacy in terms of cognitive and global measures as well as secondary efficacy outcomes of activities of daily living behavioral disturbances and AD biomarkers
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 |
|---|---|---|---|
| R21AT003302-01A1 | NIH | None | httpsreporternihgovquickSearchR21AT003302-01A1 |