Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03186989
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2017-06-06
Brief Title:
Safety Tolerability Pharmacokinetics and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimers Disease
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
Ionis Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study Followed by an Open-Label Extension to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of Intrathecally Administered ISIS 814907 in Patients With Mild Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2023-02
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 is to assess the safety tolerability pharmacokinetics and pharmacodynamics of IONIS-MAPTRx in patients with Mild Alzheimers Disease
Detailed Description:
This is a randomized double-blind placebo-controlled study followed by an Open-Label Extension in up to 44 participants This study will consist in two parts
Part 1 a randomized double-blind placebo-controlled multiple ascending dose period in participants with Mild Alzheimers Disease followed by Part 2 the open-label long-term extension period
Part 1 a randomized double-blind placebo-controlled multiple ascending dose period in participants with Mild Alzheimers Disease followed by Part 2 the open-label long-term extension period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL6003200016 | OTHER | None | None |
| 2016-002713-22 | EUDRACT_NUMBER | CCMO | None |