Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects with Alzheimer's disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Date Added
September 22nd, 2020
PRO Number
Pro00098671
Researcher
Nicholas Milano

List of Studies


Keywords
Alzheimers
Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the study drug, aducanumab in participants who have previously received aducanumab in the following previous clinical trials: Study 301 [ENGAGE]; Study 302 [EMERGE]; Study 103 [PRIME], and Study 205 [EVOLVE]. The study may last for about 2.5 years consisting of about 33 planned research clinic visits and 8 telephone safety contacts.

Institution
MUSC
Recruitment Contact
Aparna Choudhury
843-792-2845
Choudhur@musc.edu

Clinical and laboratory studies to determine the causes of neurological disease in adults and children

Date Added
September 15th, 2020
PRO Number
Pro00102718
Researcher
Catherine Ziats

List of Studies

Keywords
Alzheimers, Autism, Dementia, Epilepsy, Mental Health, Multiple Sclerosis, Parkinsons
Summary

Neurological diseases are the leading cause of disability worldwide and a major contributor to health problems in children and adults. As the majority of these conditions result in lifelong disabilities, the implications for the family and for society is significant.

A significant number of adult and childhood neurological diseases have a genetic component and are caused by changes in our DNA and/or RNA leading to functional changes in the central nervous system. However, for many patients afflicted with these disorders, traditional genetic testing does not identify a clear genetic cause. The goal of this study will be to use newer genetic techniques to evaluate patients and families with neurological disorders to better understand the genetic basis of the disease.

Institution
Self Regional
Recruitment Contact
Catherine Ziats
8642507944
cziats@ggc.org

Down syndrome biomarker project

Date Added
June 25th, 2020
PRO Number
Pro00090922
Researcher
Eric Hamlett

List of Studies


Keywords
Alzheimers, Blood Disorders, Brain, Children's Health, Dementia, Inflammation, Vascular
Summary

Alzheimer's disease and Epilepsy may affect over 80% of individuals that have Down syndrome by the age of 60. Biomarkers found in the blood can enhance our understanding of the earliest changes linked to disease and may enhance clinical detection and healthy aging for individuals with Down syndrome.

The purpose of this study is to discover early neurobiological processes underlying the transition from healthy aging to disease. Our research team has developed technology that allows detection of small changes in the brain that get transferred to the blood.

We are recruiting individuals that either have or do not have Down syndrome for this biomarker study. Participants should be between the ages of 6 months and 85 years old and may include mothers and siblings of a child with Down syndrome. Infants and children will require consent form a parental or legal guardian.

Each participant will provide a blood sample for research purposes. We will also gather some basic health information about senses, habits, exercise level and smoking/vaping exposures.

Institution
MUSC
Recruitment Contact
Eric Hamlett
919 357 7543
hamlette@musc.edu

Molecular links between Alzheimer's Disease and Cardiomyopathy

Date Added
June 16th, 2020
PRO Number
Pro00071077
Researcher
Federica del Monte

List of Studies


Keywords
Alzheimers, Dementia, Genetics, Heart
Summary

Patients with Alzheimer Disease and patients with Heart failure (and a control group free from both the previous mentioned conditions) will be evaluated with cardiac and neuropsychological assessments, in order to investigate the relationship between the two conditions. 8 follow up visits will be repeated yearly, for 8 years.

Institution
MUSC
Recruitment Contact
Gianlorenzo Daniele
843-442-6981
daniele@musc.edu

Alcohol Use Disorder as a risk for Alzheimer's Disease: Insights from functional connectome analysis

Date Added
February 18th, 2020
PRO Number
Pro00096201
Researcher
Jane Joseph

List of Studies


Keywords
Alcohol, Alzheimers, Dementia, Non-interventional, Substance Use
Summary

Alcohol Use Disorder (AUD) is a risk factor for Alzheimer's Disease (AD), but more research is needed to identify the potential mechanisms underlying this risk. The present study will use fMRI to examine brain network profiles in mid-life AUD. The goal is to develop techniques to assess risk for Alzheimer's Disease and related dementias. Participation includes cognitive testing and MRI scanning.

Institution
MUSC
Recruitment Contact
Katherine Barlis
843-792-7709
barlis@musc.edu

Odor Disturbances: Clinical Care Registry

Date Added
September 26th, 2018
PRO Number
Pro00080333
Researcher
Thomas Uhde

List of Studies


Keywords
ADD/ADHD, Adolescents, Aging, Allergy, Alzheimers, Anxiety, Asthma, Autism, Autoimmune disease, Central Nervous System, Chronic Fatigue, Depression, Environmental Factors, Fibromyalgia, Inflammation, Memory Loss, Nervous System, Parkinsons, Psychiatry
Summary

Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@musc.edu

Connectome Biomarkers for Predicting Alzheimer's Risk in Traumatic Brain Injury

Date Added
July 17th, 2018
PRO Number
Pro00077915
Researcher
Jane Joseph

List of Studies


Keywords
Aging, Alzheimers, Brain, Dementia, Healthy Volunteer Studies, Memory Loss, Military
Summary

Traumatic Brain Injury is a risk factor for Alzheimer's Disease and other dementias. This study will use neuroimaging in Veterans and civilians with a history of TBI or without TBI to understand whether some of the brain changes that occur in Alzheimer's Disease are present in people with a history of TBI. The study is recruiting male and female military Veterans or civilians with or without TBI between the ages of 30 and 65.

Institution
MUSC
Recruitment Contact
Katherine Barlis
843-792-7709
barlis@musc.edu

Using Connectomics to Characterize Risk for Alzheimer's Disease

Date Added
October 17th, 2017
PRO Number
Pro00071249
Researcher
Jane Joseph

List of Studies


Keywords
Alzheimers, Dementia
Summary

This study will use neuroimaging to understand how the connections in the brain change in Alzheimer's Disease. Changes will also be examined in individuals with mild cognitive impairment and healthy aging. The goal is to discover which brain changes are present in healthy aging and MCI so that future studies can assess the risk for developing Alzheimer's Disease. The study involves blood draw, cognitive testing, MRI, PET scanning, and a 1-year follow-up visit to repeat cognitive testing and MRI scanning.

Institution
MUSC
Recruitment Contact
Katherine Barlis
8437927709
barlis@musc.edu

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

Story-Call: e-mobile support for community caregivers of Veterans with dementia

Date Added
August 20th, 2014
PRO Number
Pro00035867
Researcher
Charlene Pope

List of Studies


Keywords
Alzheimers
Summary

Alzheimer's disease and the isolation it produces imposes a heavy burden on informal caregivers (CG) of Veterans who are persons with dementia (PWD), who carry greater burden than those caring for persons with other chronic diseases. This feasibilty study will test a mobile application (APP) on a mini-iPad designed for caregivers of community-dwelling Veterans who are PWD in comparison with Web-based informational materials. Building on story-telling interventions effective in other chronic diseases, this feasibilty study proposes Story-Call as a newly-developed mobile application that records, archives, and presents 30/60-second videos by caregivers and professionals, who share brief stories about how they have handled common dementia home-care situations, such as "She wants to go home!" A qualitative component will categorize themes from stories and in 2 phases collect: 1) perceptions from follow-up phone interviews with CG participants; and 2) focus groups with Advisory Group and VA stakeholders as a process evaluation of APP appeal, use, impact, and cultural tailoring. The expected outcomes will examine if CGs find that the APP-recorded stories decrease perceived CG burden and increase social support as efficacy, while confirming feasibility in recruitment, acceptability, practicality, increased adaptation to dementia care, and use of community resources for future scaling up and testing.

Institution
MUSC
Recruitment Contact
Charlene Pope
843-789-6577
Charlene.Pope@va.gov



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