Research is focused in three areas:
Clinical Trials for Alzheimer's Disease
TANGO
Tango is an Biogen-sponsored, phase II clinical trial that uses a monoclonal antibody designed to target tau in individuals with mild cognitive impairment or mild Alzheimer’s Disease. It is an 18-month, double-blind, placebo-controlled study that investigates this anti-tau compound to hopefully stop or slow down the progression of Alzheimer’s. This study is not currently enrolling.
EMBARK
Embark is a 2-year phase 3b open-label clinical trial of a disease-modifying therapy for Alzheimer’s Disease (AD), sponsored by Biogen Idec. The trial investigates the potential of aducanumab, a monoclonal antibody targeting amyloid plaque, to slow or stop the disease progression in patients with early-stage AD. The FDA is currently reviewing aducanumab and will decide whether to approve the drug for use by early June. This study is not currently enrolling.
CLARITY-AD
Clarity-AD is a phase III clinical trial sponsored by Eisai that uses a monoclonal antibody designed to target amyloid in individuals with mild to moderate Alzheimer's Disease. It is an 18-month, double-blind, placebo-controlled study that investigates the safety and efficacy of the anti-amyloid compound. This study is not currently enrolling.
NRAD
NRAD is an NIH-funded, open-label, 12-week long brain imaging research study looking at the effects of a Vitamin B3 dietary supplement, Nicotinamide Riboside (NR), on brain metabolism in those with Mild Cognitive Impairment (MCI) or mild Alzheimer’s Disease (AD). This study is currently enrolling.
Behavioral Symptoms of Alzheimer's Disease
Cannabinoid-Based Therapy
Dronabinol (THC-AD)
Dronabinol is an in-patient pilot trial of a dronabinol-adjunctive treatment of agitation in Alzheimer’s Disease is being done to determine whether dronabinol is an effective and safe treatment for agitation in AD. Dronabinol is a synthetic drug version of tetrahydrocannabinol (THC), the main psychoactive ingredient in marijuana. This study is currently enrolling.
Caring for Behavioral Symptoms of Dementia (CBD-AD)
CBD-AD is an outpatient 8-week open-label clinical trial of a custom formulated high-CBD/low-THC sublingual solution to test the safety and efficacy of its use in treating anxiety and agitation in older adults with mild to moderate Alzheimer's disease. The solution was developed by Staci Gruber, PhD, here at McLean Hospital. This study is currently enrolling.
Electroconvulsive Therapy (ECT)
ECT-AD
ECT-AD is a multisite, randomized, placebo-controlled inpatient trial aiming to determine the safety and efficacy of electroconvulsive therapy in the treatment of refractory agitation and aggression in patients with Alzheimer's Disease. This study is currently enrolling.
Mood Disorders
Low Field Magnetic Stimulation (LFMS)
Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression is a study examining changes in brain activity after the use of low-field magnetic stimulation (LFMS). LFMS involves a series of electromagnetic pulses to the brain, with no physical sensation associated with its usage. The study is investigating the antidepressant effects LFMS has on older adults with bipolar disorder who are currently depressed. We use fMRI to examine these brain changes. This study is currently enrolling.
Geriatric Mood Disorders Database (GMDD)
GMDD is a three-year, longitudinal study of cognition and mood in older adults with and without the diagnoses of mood disorders. The study seeks to compare differences in cognition and functioning during the aging process in subjects with mood disorders and subjects without mood disorders. It is funded by the Rogers Family Foundation. This study is currently enrolling.
Link Between Inflammation, Executive Function, and Treatment Resistant Depression (LIFT)
LIFT is a pilot study to assess the relationship between inflammation, attention/executive function, and treatment resistance in older adults with treatment refractory depression. The study will measure differences in attention/executive functioning in older adults with treatment resistant depression compared to age-matched healthy controls. This study is currently enrolling.
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