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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease | Clinical Trials | Clareo Health

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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

NCT03186989•Ionis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females aged 50-74 years, inclusive, at the time of informed consent
•Diagnosed with mild Alzheimers disease, including CSF biomarkers consistent with this diagnosis
•Body Mass Index BMI ≥ 18 and ≤ 35 kg/m2 and total body weight \> 50 kg (110 lbs)
•Able and willing to meet all study requirements, including toleration for MRI scans, blood draws and lumbar punctures, travel to Study Center and participation in all procedures and measurements at study visits
•Have a trial partner who is reliable, competent and at least 18 years of age, is willing to accompany the patient to select trial visits and to be available to the Study Center by phone if needed
•Reside within 4 hours travel of the Study Center
•Must have completed the Treatment Evaluation and Post-Treatment Periods in Part 1

Exclusion Criteria

•Treatment with another Study Drug, biological agent, or device within one-month of Screening or 5 half-lives of investigational agent, whichever is longer
•Clinically significant medical condition which would make the patient unsuitable for inclusion or could interfere with the patient participating in or completing the study
•Use of a disallowed CNS-active or antipsychotic medication within 4 weeks prior to Screening punctures
•Treatment with another Study Drug, biological agent, or device within one-month of Screening or 5 half-lives of investigational agent, whichever is longer
•Clinically significant medical condition which would make the patient unsuitable for inclusion or could interfere with the patient participating in or completing the study
•Use of a disallowed CNS-active or antipsychotic medication within 4 weeks prior to Screening punctures

Locations (13)

Montreal Neurological Hospital

Montreal, Canada

Clinical Research Services Turku CRST

Turku, Finland

St Josef Hospital

Bochum, Germany

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)

Bonn, Germany

MVZ Mittweida Gbr

Mittweida, Germany

Universittsklinikum Ulm

Ulm, Germany

VU University Medical Center

Amsterdam, Netherlands

QPS Netherlands BV

Groningen, Netherlands

Minnesmottagningen

Mölndal, Sweden

Karolinska University Hospital Huddinge

Stockholm, Sweden

Key Dates

Start Date

October 12, 2017

Primary Completion Date

May 12, 2022

Completion Date

May 12, 2022

Last Updated

April 8, 2025

Enrollment

ACTUAL participants

Conditions

Mild Alzheimer's Disease

Interventions

IONIS MAPTRx

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease

Medicare Anti-Aβ mAb Coverage With Evidence Development (CED) Study

WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease