NCT03186989

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease

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 Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS-MAPTRx in patients with Mild Alzheimer's Disease.

Detailed description

This was a randomized, double-blind, placebo-controlled study in 46 participants, followed by an Open-Label Extension. This study consisted of two parts: Part 1: a randomized, double-blind, placebo-controlled multiple ascending dose period in participants with Mild Alzheimer's Disease, followed by Part 2: the open-label, long-term extension period.

Conditions

• Mild Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	IONIS MAPTRx	IONIS MAPTRx injections.
OTHER	Placebo	Artificial CSF injections.

Timeline

• Start date: 2017-10-12
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2017-06-14
• Last updated: 2025-04-08
• Results posted: 2025-04-08

Locations

13 sites across 6 countries: Canada, Finland, Germany, Netherlands, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study