A clinical trial is a study to test the effectiveness of a drug or a technique to diagnose, treat or possibly even prevent a medical condition. All participants are volunteers; no one is required to be in a clinical trial. Not all individuals are eligible for clinical trials, but those who are and who agree to take part after talking to their doctors are making important contributions to medical science.
Montefiore has several clinical trials testing diagnostic techniques and treatment methods for Alzheimer’s disease:
- Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
The study aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective and functioning outcomes. Psychotherapy, also known as talking therapy, is the use of psychological methods to help a person change and overcome problems in desired ways. PATH-MCI differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.
A second study of the PATH methodology, funded by the Leslie R. Samuels and Fan Fox Foundation, is directed at frail older adults who are high risk for cognitive impairment and depression and who have chronic kidney disease. This study is an in-home or office-based counseling program that focuses on the patient, the caregiver and the patient’s home environment to encourage problem-solving and strategies to adapt to memory and functional problems.
- Transcranial Direct Current Stimulation (tDCS) in Mild to Moderate Alzheimer’s Disease (AD) Patients
The prevalence of Alzheimer’s Disease (AD) is rising, but existing medications provide only modest control of cognitive decline and associated symptoms, and novel therapies are urgently needed. This randomized sham-controlled trial will determine if an innovative low-risk remotely-supervised transcranial Direct Current Stimulation (tDCS) applied over the area of the dorsolateral prefrontal cortex for 30 minutes at the intensity of 2 mA five times per week for 6 months at home can improve cognitive performance and symptoms and modulate neuroimaging markers of neuroplasticity in 100 patients with mild to moderate AD. If effective, this novel intervention can substantially enhance AD symptom management at home, improve quality of life of AD patients and their families, and reduce burden associated with this debilitating illness.
- New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study
The study uses Medicare claims data to (1) compare health outcomes in amyloid PET-positive versus amyloid PET-negative individuals presenting with Mild Cognitive Impairment (MCI) and dementia; (2) to describe the association of amyloid PET findings with changes in patient management and 12–month health outcomes among Blacks/African Americans, Latinx/Hispanics and Whites/Caucasians presenting with MCI and dementia; and (3) to describe the association of amyloid PET findings with changes in management and 12-month health outcomes in individuals presenting with typical (progressive amnestic) versus atypical clinical presentations of MCI and Alzheimer’s disease.
For more information about these trials, call Montefiore at 914-375-4880.
The National Institutes of Health has extensive information on Alzheimer’s Disease trials at click here
The Alzheimer’s Association also has a listing of clinical trials at click here