Phase II Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)

We are doing this study to better understand the link between stress and memory problems. When individuals are in stressful situations, their bodies make “stress” hormones that can have negative effects on brain areas that control memory. Individuals with Alzheimer’s disease have higher levels of stress hormones than individuals without this disease.

In this study, we are testing the effects of a new drug, called CORT108297, which was developed to block stress hormones from attaching to brain areas related to memory. Our goal is to determine whether this drug is effective in improving memory in individuals with memory impairment and/or in those who have no memory impairment but are at risk for Alzheimer’s disease.

This study will involve 7 in-person visits over 10-12 weeks at the Johns Hopkins Bayview campus. Healthy individuals with memory impairment or who have no memory impairment but have concerns about developing Alzheimer’s disease, and are at least 55 years old, can participate. To hear more information regarding this study, please call us at 410-550-6271 or email study coordinator Nick Bienko at [email protected].
Principal investigator: Cynthia A. Munro, Ph.D. (IRB00227116)

Deep brain stimulation for Mild dementia or Alzheimer’s disease (ADvance II)

Deep brain stimulation (DBS) is the use of a surgically implanted device that delivers mild electrical pulses to the fornix, an area of the brain that plays a central role in memory. Currently, DBS is FDA approved for the treatment of disabling symptoms of Parkinson’s disease and other neurologic conditions. In this study, we are looking to evaluate the effectiveness of deep brain stimulation of the fornix to slow the cognitive decline associated with Alzheimer’s. Individual with a diagnosis of dementia or mild Alzheimer’s disease, is 65 years or older, and is willing to undergo neurosurgery may be eligible for the study.

The study will involve 12 clinic visits over 48 months at Johns Hopkins Bayview Campus. Participants in the trial will be compensated for their time and transportation. To hear more information regarding this study, please call us at (410) 550-4969 or email [email protected]. Principle investigator: Paul Rosenberg, M.D. (IRB00181686).

Apathy in Dementia Study

(ADMET II Trial)

Apathy is one of the most prevalent neuropsychiatric symptoms in individuals with Alzheimer’s disease.Up to 50% of people with dementia experience this loss of will and initiative, lack of interest in activities,lack of productivity, or lack of response to events in their life. The goal of the ADMET II study is to see ifmethylphenidate can help lessen the effects of apathy in Alzheimer’s disease. Also known as Ritalin, methylphenidate is approved for use in the treatment of attention Deficit/Hyperactivity Disorder by the FDA, and previous trials have suggested it may be helpful in treating apathy in Alzheimer’s disease. Individuals in the ADMET II trial will be asked to take methylphenidate or placebo for 6 months and attend about 7 clinic visits at Johns Hopkins at Bayview. If you are interested in learning more about this trial, call 410-550-9022. Principal Investigator: Paul Rosenberg, M.D. (JHU protocol number IRB00064958)

BDPP Treatment for Mild Memory Loss and Prediabetes

The combination of memory problems and abnormal blood sugar has been shown to be a risk factor for developing Alzheimer’s disease, and a nutraceutical (“health food”) is being investigated to target this problem. This trial is seeking individuals between the ages of 50-90 who are concerned that they may be experiencing memory loss. BDPP is a combination of resveratrol (a chemical found in the skin of grapes) and grape seed extract. Study investigators hope to learn if BDPP could help maintain memory or decrease the amount of abnormal proteins in the brain. Individuals in this study will be asked to take BDPP or placebo for 4 months and attend about 9 research visits to Johns Hopkins at Bayview. Glucose testing and a memory evaluation are provided as part of the trial. Please call 410-550-6486 for more information on how to enroll. Principal investigator: Paul Rosenberg, M.D. (IRB protocol number IRB00062802)

Circadian Rhythm Disturbance in Agitation of Alzheimer’s Disease

(The Actigraphy in Agitation Study)

Agitation in Alzheimer’s disease can be challenging for affected individuals and the people who care for them. Some researchers think that agitation in Alzheimer’s disease may be caused by changes in a person’s normal sleep cycle. Individuals with these changes may become more likely to become restless, wander and pace, resist help with daily activities, or become hard to handle at certain times in the day. The goal of the Actigraphy in Agitation study is to learn more about changes in sleep patterns that occur in people with Alzheimer’s disease. The Actigraphy in Agitation study is looking for people who have Alzheimer’s disease with or without symptoms of agitation including pacing, resisting care, and restlessness. Participants in the Actigraphy in Agitation study will be asked to attend 1 clinic visit at Johns Hopkins at Bayview, wear a device the size of a wrist watch on their wrist for 7 days and use two devices to help researchers learn about their sleep patterns. The study team will provide all of the required equipment at no cost. If you are interested in learning more about this trial, please contact John Outen at 410-550-7385 or [email protected]. Principal Investigator: Paul Rosenberg, M.D. (JHU protocol number IRB00151016). Download flyer.

Escitalopram for Agitation in Alzheimer’s Disease (S-CitAD)

Agitation is common in people who have Alzheimer’s disease (AD) and can be can be a challenging behavior for the family and friends of these individuals. Agitation affects 42-60 percent of people with Alzheimer’s Disease, and involves emotional distress, excess psychomotor activity, aggression, or disinhibition. Treatment options for agitation in AD are limited. Current approaches are inadequate and better approaches are needed. S-CitAD is a placebo-controlled, masked, randomized clinical trial, sponsored by the National Institute on Aging (NIA). The study is designed to examine the efficacy and safety of escitalopram in combination with a psychosocial intervention (PSI) as treatment for agitation in AD patients. Individuals in the S-CitAD trial will be enrolled for 24-weeks, with treatment for 12 weeks, and additional 12 weeks of safety and efficacy follow-up, for a total of 6 clinic visits at Johns Hopkins University. If you are interested in learning more about this trial, call (410) 550-9022. Site Investigator: Paul Rosenberg, MD. (Principal Investigator: Constantine Lyketsos, MD; Protocol number: IRB00148995)

Geriatric Depression Study

Are you over 60 and feeling depressed? Symptoms of depression in older adults are common yet often go undetected. Symptoms could include feelings of sadness or hopelessness, loss of energy, inability to enjoy pleasurable activities, changes in appetite or sleeping patterns, or poor concentration/memory. If you are feeling depressed, not taking antidepressant medication and in good physical health you may be eligible to participate in a research study involving treatment. Qualified people will participate at no cost to them and will be compensated for their time and transportation. For more information about the research study, please call us at 410-550-4192 or email us at [email protected] . Principal Investigator: Gwenn Smith, PhD (IRB Protocol No: NA_00021615) Download PDF flyer

A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia (FOXY)

The FOXY trial is for people between the ages of 30-80 who have frontotemporal dementia (FTD). The FOXY trial aims to help researchers learn if giving Oxytocin to people who have FTD may be helpful in reducing social apathy, indifference, and lack of empathy. These traits are common in people who have FTD and can be burdensome for family and friends. You may qualify for this study if you have been diagnosed FTD, display symptoms of moderate social apathy/indifference, and have someone willing to act as a study partner.

People who join this trial will be given Oxytocin or placebo for about 18 weeks. There will be 5 clinic visits and 2 telephone calls that will occur will taking study drug (or placebo). During 4 of the visits, we will ask you to eat a meal at the clinic while we film you. Please call (410)-550-6486 or e-mail [email protected] for more information on how to enroll. Principal Investigator: Chiadi Onyike, M.D. (IRB protocol number IRB00146529)

Memory & Aging Study

The Johns Hopkins Memory Center is currently conducting a study of the differences between normal aging, mild memory problems, and the onset of memory disorders like Alzheimer’s Disease. If you choose to participate in the Memory and Aging Study, you and a study partner will be invited to our clinic for a 2-3 hour assessment including memory testing, physical exam, and blood samples. We will ask you and your study partner questions about your daily functioning. You will return to our clinic once a year for an annual physical exam and memory testing. People, 60 years old or older, with or without memory problems, can participate in this study. If you are interested in learning more about this study please call Irene Giorgakis at 410-550-9021. Constantine Lyketsos, MD, MPH, Principal Investigator (JHU IRB Application No: NA_00045104)

Mild Cognitive Impairment Study

Are you more forgetful lately? Do you have trouble with the names of people you’ve met recently? Do you get lost in new places? Do you have a greater tendency to misplace things? Do other people notice that you are forgetful? If you are age 55 or over, having memory problems, not taking antidepressant medication and in good health, you may be eligible to participate in a research study. Qualified people will participate at no cost to them and will be compensated for their time and transportation. For more information about the research study, please call us at 410-550-4192 or email us at [email protected]. (Principal Investigator: Gwenn Smith, PhD, IRB Protocol No: NA_00026190) Download flyer.

Neural Network Connectivity of Financial Capacity in Mild Cognitive Impairment (The NCFC Study)

Managing money and personal finances are daily activities for most people. Individuals with Mild Cognitive Impairment (MCI) may have difficulty managing their money and making financial decisions. This may lead to poor outcomes, including increase in conflict within families, financial victimization, and the onset of dementia. Researchers in the Neural Network Connectivity of Financial Capacity Study want to learn more about how brain changes affect financial skills through the use of Magnetic Resonance Imaging (MRI). Individuals with or without MCI greater than 65 years old may be eligible. Participants in the NCFC study will be asked to attend 1 clinic visit at Johns Hopkins at Bayview for neurocognitive testing and 1 visit at the Kennedy Krieger Institute in East Baltimore for a state-of-the-art MRI of the brain. If you are interested in learning more about this trial, please contact John Outen at 410-550-7385 or [email protected]. Principal Investigator: Milap Nowrangi, M.D. (JHU protocol number IRB00129816). Download flyer.

Oral Glucose Tolerance Test for Alzheimer’s Disease Biomarker Development

The purpose of this research is to find if there is a relationship between a chemical in the blood, which may be related to memory problems, and the body’s hormonal response from the pancreas, gut, and fat tissue after an oral glucose tolerance test. People with and without memory problems may join this study. The study involves a memory screening test and an oral glucose tolerance test. The results of these tests will help us with our research study related to memory, aging, and hormones. If you are interested in learning more about this study please call 410-550-4969. Esther Oh, M.D., Principal Investigator (JHU IRB Application No.: NA_00014837)

Problem Adaptation Therapy for Mild Cognitive Impairment and Depression (PATH-MCI)

Johns Hopkins Memory and Alzheimer’s Treatment Center is looking for volunteers to participate in a research study, called PATH-MCI, which is testing if psychotherapy intervention (also known as talk therapy) is effective in helping individuals with mild memory problems and depression symptoms with their cognition, mood, and function. If you are between the ages of 60-85 years old, diagnosed with mild memory problems and experience depression symptoms, you may be eligible for PATH-MCI. For more information or to see if you qualify, contact us at (410) 550-9022 or [email protected] (Principal Investigator: Paul Rosenberg, MD; Protocol number: IRB00063914)