Clinical Trials

The Memory Program provides patients with opportunities to take part in clinical trials for new medications and other treatments for preventing, curing or improving loss of memory. Participants who qualify for these scientific research studies receive the following:

  • Full medical examination and assessment
  • Regular checkups with our experienced physicians
  • Access to the latest treatments – sometimes for long periods of time even after the clinical trial is over

Also, participants in clinical trials help advance medical research and find new ways to prevent, halt and restore memory loss.

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Clinical Trials at The UM Memory Program

    A Allogeneic Human Mesenchymal Stem Cell Infusion Versus Placebo in Patients With Alzheimer’s Disease

    This is a randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) or placebo in subjects with Alzheimer’s Disease. Following a successful Safety Run-In Phase, a total of twenty-five (25) subjects will be randomized to (2:2:1) to receive low-dose LMSCs, high-dose LMSCs or placebo. After randomization, baseline imaging, and study product infusion, subjects will be followed up at 2, 6, 13, 39 and 52 week post study product infusion. Intention-to-treat study population will be used for the purpose of the endpoint analysis and safety evaluations.

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    A pilot study of ocular microvascular dysfunction and retinal microstructural alteration in mild cognitive impairment (MCI) and Alzheimer’s Disease (AD)

    The purpose of this study is to characterize the eye’s retinal and conjunctival microvascular dysfunction in MCI and AD, and identify their relationship with the eye’s retinal microstructural changes.

    Efficacy, Safety, and Tolerability of Subjects with Agitation Associated with Dementia of the Alzheimer’s Type

    This research study investigates the efficacy, safety, and tolerability of brexpiprazole (OPC-34712) on subjects that show evidence of agitation associated with dementia of the Alzheimer’s type. Subjects will either receive the active drug or placebo in a randomized fashion, over the course of 12 weeks. Brexpiprazole is an orally administered dopamine  agonist that may be beneficial in altering agitation and other behavioral symptoms associated with Alzheimer’s disease (AD).

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    Evelyn F. McKnight Brain Institute Cognitive Disorders Clinical and Bio-repository Registry – Collection

    Participants will be enrolled from the University of Miami Memory Disorders Clinic, a collaborative effort between Neurology and Psychiatry & Behavioral Sciences. The data bank will collect information on patient demographics, clinical assessments, medical history, familiar risk factors, imaging data, and treatment modalities.

    The objectives of the clinical data bank/ biorepository include:

    • Understanding the demographics and risk factors for dementia and its subtypes that may lead to improvements in patient care.
    • Monitoring of compliance with dementia treatment recommendations, to better understand compliance issues and treatment outcomes.
    • Accumulate a pool of data from which basic and applied research projects related to patients suffering from neurodegenerative and other dementing diseases may evolve.
    • Identify biomarkers that predict the development of Alzheimer’s disease in patients with memory complaints or Mild Cognitive Impairment (MCI) and family members of affected patients with AD.

    Impaired retinal microcirculation in patients with Alzheimer’s disease

    Impaired retinal microcirculation in patients with Alzheimer’s disease

    Authors:

    Jiang H1,2Liu Y1,3Wei Y1,4Shi Y1Wright CB5Sun X2Rundek T2Baumel BS2Landman J2Wang J1.

    Abstract:

    The goal of this study was to determine the retinal blood flow rate (BFR) and blood flow velocity (BFV) of pre-capillary arterioles and post-capillary venules in patients with mild cognitive impairment (MCI) and Alzheimer’s disease (AD). Forty patients (20 AD and 20 MCI) and 21 cognitively normal (CN) controls with a similar age range (± 5 yrs) were recruited. A retinal function imager (RFI) was used to measure BFRs and BFVs of arterioles and venules in the macular region. The thickness of the ganglion cell-inner plexiform layer (GCIPL) was measured using Zeiss Cirrus optical coherence tomography. Macular BFRs in AD group were 2.64 ± 0.20 nl/s (mean ± standard deviation) in arterioles and 2.23 ± 0.19 nl/s in venules, which were significantly lower than in MCI and CN groups (P < 0.05). In addition, BFRs in MCI were lower than in CN in both arterioles and venules (P < 0.05). The BFV of the arterioles was 3.20 ± 1.07 mm/s in AD patients, which was significantly lower than in CN controls (3.91 ± 0.77 mm/s, P = 0.01). The thicknesses of GCIPL in patients with AD and MCI were significantly lower than in CN controls (P < 0.05). Neither BFV nor BFR in arterioles and venules was related to age, GCIPL thickness, mini mental state examination (MMSE) score and disease duration in patients with AD and MCI (P > 0.05). The lower BFR in both arterioles and venules in AD and MCI patients together with the loss of GCIPL were evident, indicating the impairment of the two components in the neurovascular-hemodynamic system, which may play a role in disease progression.

    https://www.ncbi.nlm.nih.gov/pubmed/29394263

    1. Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, United States of America
    2. Evelyn F. McKnight Brain Institute, Department of Neurology, University of Miami Miller School of Medicine, Miami, FL, United States of America
    3. Department of Ophthalmology, Third Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China
    4. Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guangzhou, Guangdong, China

    5. National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, United States of

    America

    Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer’s Disease

    This Phase III study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of early AD. The study will evaluate safety and tolerability, efficacy as measured by CDR-SB, and will determine if the combination therapy ALZT-OP1 will slow down, arrests, or reverse cognitive and functional decline in an early stage AD population.

    Subjects will be randomly assigned to one of four treatment arms: Group I will consist of ALZT-OP1a (cromolyn) for inhalation, plus an oral placebo tablet; OR the Group II arm, which will consist of ALZT-OP1 combination therapy ALZT-OP1a (cromolyn) for inhalation, plus ALZT-OP1b (ibuprofen) tablet for oral administration; OR to the Group III arm, which will consist of inhaled placebo, plus ALZT-OP1b (ibuprofen) tablet for oral administration; OR to the Group IV placebo arm, which will consist of inhaled placebo plus an oral placebo tablet.

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    Treatment of Psychosis and Agitation in Alzheimer’s Disease

    Symptoms of psychosis or agitation are common in Alzheimer’s disease. These symptoms are associated with distress for the patient, an increased burden for caregivers, more rapid cognitive decline, greater risk of institutionalization and mortality, and increased health care costs. In a recent meta-analysis, caregiver education and behavior modification studies revealed a small to medium effect size in treating agitation in these patients. However, none of these studies were double-blind (difficult to achieve in such studies) and none had a control group that received the same amount of staff time as the intervention group, thereby biasing the results toward the active intervention.

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About Clinical Trials

What is a clinical trial?
A clinical trial involves research using volunteer participants that is designed to add to medical knowledge. By participating in a study, you can help our researchers learn more about treating memory loss and improving an individual’s quality of life.

Every drug that doctors prescribe is first tested and then proven effective in a clinical trial. At the UM Memory Program we are committed to develop new treatments for memory loss. We work with leaders from all over the country in programs aimed at solving the problems of dementia. Our goal is to find the right treatment to improve, prevent or cure memory loss. Patients who participate in these clinical trials have the opportunity to test the latest memory loss therapies.

What are the benefits?
As a participant you have access to our UHealth medical team throughout the study. You may also be eligible for further services after the study is over.

Will I know the purpose of the study?
Yes. Our team will explain exactly what the study is designed to do and what your role would be, if you are accepted to take part.

Are clinical trials safe?
Safety is always a top priority, and any clinical trial must be approved by our Institutional Review Board, a team of doctors, experts and members of the community. We want to be sure that the study will be safe for participants and help researchers  learn more about memory loss.

How can I enroll?
All clinical trials have certain requirements for participation, so not every patient is eligible to enroll. However, new clinical trials begin frequently, we encourage individuals to stay in touch with our program.

Where can I learn more about clinical trials?
The U.S. government has extensive information on its Clinical Trials website.