Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer's Disease.

Date Added
November 9th, 2023
PRO Number
Pro00128555
Researcher
Jacobo Mintzer

List of Studies


Keywords
Alzheimers, Dementia
Summary

About 380 males and females aged 55 to 90 years with psychosis associated with Alzheimer's disease will take part in this worldwide study. This study will be conducted at up to 100 sites in the United States, Canada, France, Germany, Spain and others in approximately 10 countries. The study will test KarXT, a combination of 2 study drugs, xanomeline tartrate and trospium chloride. Xanomeline tartrate stimulates the muscarinic receptors (a receptor in the nervous system) that is involved in cognitive and neurobehavioral functions. Stimulation of these receptors has been shown to effect changes in cognitive performance and promote antipsychotic activity. Trospium chloride is a muscarinic inhibitor that is expected to reduce the negative peripheral (outside the brain) muscarinic side effects of xanomeline tartrate without reducing its intended therapeutic effects in the brain.
The goal of this study is to assess whether KarXT helps in relapse prevention in people with psychosis associated with AD as compared to placebo, see how safe and well accepted KarXT is in people with psychosis associated with AD as compared to placebo, and check what the body does to KarXT and how long does it stay in the body (pharmacokinetics) as compared to placebo.

Institution
MUSC
Recruitment Contact
Mia Cokley
8437926810
cokleym@musc.edu

Registry of Recruitment-Ready Research Participants for Alzheimer's Disease-Related Clinical Trials

Date Added
October 5th, 2021
PRO Number
Pro00112875
Researcher
Jacobo Mintzer

List of Studies


Keywords
Alzheimers
Summary

The purpose of the Alzheimer's Disease Registry Study (ADRS) is to (1) create a registry that will continue to provide study-ready subjects who meet research diagnostic criteria for the different stages of AD and who have been evaluated using research instruments that allow for their participation in clinical trial research, (2) provide a platform to allow for continual follow-up with registry participants to allow for their participation in clinical trial research at different stages of the disease process, and (3) to incorporate a population of veterans and minorities suffering from AD, a population that is not proportionally represented in clinical trial research, into the registry.

By collecting data pertaining to medical history, current medication details, family history, vital signs, and memory/thinking symptom concerns and evaluating a subject's ability to perform certain tasks, such as memory and thinking tests, questions about their daily activities, and social functioning; researchers are able to determine a research subject's potential eligibility in a clinical trial research protocol.

A registry with such information would enable researchers to effectively and efficiently identify potentially eligible research subjects for the program's evolving portfolio of Alzheimer's disease-related clinical trials.

Institution
MUSC
Recruitment Contact
Allison Lapp
843-608-1950, ext 1109
allisonlapp@lcvresearch.org

Apathy in Dementia Methylphenidate Trial 2 (ADMET 2)

Date Added
September 23rd, 2015
PRO Number
Pro00043151
Researcher
Jacobo Mintzer

List of Studies


Keywords
Aging, Alzheimers, Brain
Summary

With this research study, we want to learn if methylphenidate (RitalinĀ® and others) helps people with Alzheimer's disease and apathy (lack of interest or concern for things that others find moving or exciting).

Institution
MUSC
Recruitment Contact
Allison Lapp
843-724-2302
Allison.Lapp@rsfh.com



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