Research in the Frontotemporal Dementia and Young-Onset Dementias Clinic covers a range of topics relating to the mechanisms and manifestations of the diseases, the costs and burdens of caring for sufferers, the quality of care and services, and the identification and development of effective treatments. The National Institute on Aging provides the primary financial support for our work through the Johns Hopkins Alzheimer’s Disease and Related Disorders Center, and our partnerships with advocacy organizations and the biomedical industry provide additional resources and perspective. Private foundations and individual donors also provide generous support for treatment and quality of care studies. We also collaborate with a variety of other university research programs.

Our current research studies focus on the following diseases:

• Frontotemporal Dementias and Related Disorders
• Young-Onset Dementias (i.e. dementias manifesting in mid-life)

Specific topics covered by our research include:

• Disease manifestations and diagnostic methods
• Clinical epidemiology (studies of risk factors and natural history)
• Studies of neuropathologic, molecular, and genetic characteristics
• Clinical trials and other treatment studies
• Career burden and quality of care

Frontotemporal Dementias and Young-Onset Dementias

• Remote Blood Biomarker Monitoring in Frontotemporal Lobar Degeneration: Neurofilament Surveillance Project (NSP) 
• A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia (FOXY)
• A Study to Evaluate Efficacy and Safety of AL001 in FTD (INFRONT-3) 
• Measurement of the Clinical Progression and Severity of Frontotemporal Dementia

Remote Blood Biomarker Monitoring in Frontotemporal Lobar Degeneration: Neurofilament Surveillance Project (NSP)

Principal investigator: Chiadi Onyike, M.D., M.H.S.
Research Program Administrator: Ann Fishman

The primary goal of this multi-site is to measure the levels of a protein called neurofilament light chain in the blood of individuals who are members of family with genetic FTD. Neurofilament light chain is a protein that is found in nerve fibers and is released when they are damaged or die. It is thought that the levels of this protein in blood may act as a biomarker, or biological marker, that may be able to give information about the onset or progression of FTD.

A research nurse will visit the participant’s home, office, or a place of choice approximately every three months for three years. During the visit, a research nurse will draw and prepare a blood sample to use for measurements of neurofilament light chain. This is an ancillary study to the ARTFL-LEFFTDS Longitudinal FTD (ALLFTD) study and one must be a participant in ALLFTD to participate. More information about the study is available at the ALLFTD website.

Contact:
410-502-5816 or  [email protected]

Location:
The Johns Hopkins Hospital
Division of Geriatric Psychiatry and Neuropsychiatry
600 N. Wolfe Street, Suite 235
Baltimore, Maryland 21287

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

Principal Investigator: Chiadi Onyike, M.D., M.H.S.
Research Program Administrator: Ann Fishman

The primary goal of this study is to determine whether 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 caregivers, such as family and friends. Patients who have been diagnosed with FTD, display symptoms of moderate social apathy/indifference, and have someone willing to act as a study partner may qualify for this study.

The study plans to enroll 110 participants at medical centers in Canada and the US. People who join this trial will be given Oxytocin or placebo for about 18 weeks. There will be five clinic visits and two telephone calls that will occur while taking study drug (or placebo). During four of the visits, participants are asked to eat a meal at the clinic while being filmed. More information about the study could be found by visiting the FOXY website.

Contact:
410-502-5816 or  [email protected]

Location:
The Johns Hopkins Hospital
Division of Geriatric Psychiatry and Neuropsychiatry
600 N. Wolfe Street, Suite 235
Baltimore, Maryland 21287

A Study to Evaluate Efficacy and Safety of AL001 in FTD (INFRONT-3)

Principal Investigator:  Chiadi Onyike, M.D., M.H.S.
Research Program Administrator: Ann Fishman

The primary goal of this phase 3 clinical research study is to examine if increasing progranulin levels after treatment with AL001 will delay the onset of symptoms or slow disease progression when compared to a placebo. Participants need to have a confirmed progranulin gene mutation and either be diagnosed with FTD or at risk of developing FTD symptoms as evidenced by a biomarker.

The study plans to enroll 180 participants at 80 centers globally. The study drug (AL001 or placebo) will be administered every four weeks by an intravenous (IV) infusion. Assessments will include regular medical examinations, blood tests, brain imaging, and completion of questionnaires. AL001 has not been approved by the FDA or any other health authority approval around the world. More information about the study could be found by visiting the INFRONT-3 website.

Contact: 410-502-5816 or  [email protected]

Location:
The Johns Hopkins Hospital
Division of Geriatric Psychiatry and Neuropsychiatry
600 N. Wolfe Street, Suite 235
Baltimore, Maryland 21287

Measurement of the Clinical Progression and Severity of Frontotemporal Dementia

Principal Investigator: Chiadi Onyike, M.D., M.H.S.

Advancements in our understanding of the neurobiology of the FTDs have spurred interest in the development of measures that can track the progression of subtypes of FTD over the entire span of the disease.  This study examines how cognitive, behavioral, and functional deterioration unfolds in FTD, with an eye towards the identification of clinical staging markers and the development of an instrument that can be used in practice and research to track disease progression.  All individuals who have FTD and receive their care from the clinic are eligible for the study.

Contact: 410-955-5147 or [email protected]

Location:
The Johns Hopkins Hospital
Division of Geriatric Psychiatry and Neuropsychiatry
600 N. Wolfe Street, Suite 235
Baltimore, Maryland 21287

Young-Onset Dementias

Longitudinal Early-Onset Alzheimer’s Disease Study (LEADS)

Principal Investigator: Chiadi U. Onyike, M.D., M.H.S.
Research Program Administrator: Ann Fishman

This study explores the development of early-onset Alzheimer’s disease and how it compares to the more common late-onset Alzheimer’s variant. The primary goal is to develop sensitive clinical and biomarker measures for future clinical and research use.

The study plans to enroll and follow 500 cognitively impaired participants and 100 cognitively normal participants ages 40-64 years at approximately 15 sites in the United States. Participants will perform study activities including medical and neurological exams, cognitive testing, biofluid sample collection, and neuroimaging (MRI & PET scan) at the beginning of their involvement. Those with memory problems will repeat the activities every year for four years, for a total of five visits; participants without memory problems will repeat the activities every year for two years, for a total of three visits. Individuals younger than 65 with mild cognitive impairment (MCI) or dementia of mild severity suspected to be caused by Alzheimer’s disease may qualify for this study. For more information, visit the LEADS website.

Contact: 410-502-5816 or  [email protected]

Location:
The Johns Hopkins Hospital
Division of Geriatric Psychiatry and Neuropsychiatry
600 N. Wolfe Street, Suite 235
Baltimore, Maryland 21287