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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    221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer’s Disease (ENGAGE)

    The purpose of this Phase 3 study is to assess the efficacy and safety of aducanumab compared with placebo in subjects with early Alzheimer’s Disease (AD), including mild cognitive impairment (MCI) due to AD and a subset of mild AD. Aducanumab is a human monoclonal antibody that recognizes aggregated forms of β-amyloid (Aβ), including soluble Aβ oligomers and deposited fibrillar Aβ. Interim analyses of the ongoing multiple dose study (Study 221AD103) have demonstrated target engagement, a pharmacodynamic effect on amyloid reduction, and an effect on the Clinical Dementia Rating (CDR)-Sum of Boxes (SB) and Mini-Mental State Examination (MMSE) suggestive of a reduction in the progression of clinical impairment for aducanumab-treated subjects. These results along with the observed safety and tolerability profile warrant further Phase 3 investigation of aducanumab in a patient population spanning the early stages of the AD continuum.

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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.

    A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer’s Disease Dementia (The DAYBREAK-ALZ Study)

    LY3314814 is a brain-permeable inhibitor of human Beta-site amyloid precursor protein-cleaving enzyme 1 (BACE1/β-secretase). It is being developed for the modification of the clinical course of Alzheimer’s disease (AD) by slowing disease progression in patients diagnosed with early Alzheimer’s Dementia (which is defined as mild cognitive impairment (MCI) due to AD and mild dementia of the AD type). The current study, I8D-MC-AZET, will
    enroll patients with mild dementia of the AD type.
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    A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer’s Disease (Generation)

    This study will assess the effects of each of the two therapies given separately, both targeting amyloid, on cognition, global clinical status, and underlying pathology in participants at risk for the onset of clinical symptoms of Alzheimer’s disease (AD). Cognitively unimpaired individuals with two APOE4 genes and age 60 to 75 years, inclusive, are selected as they represent a population at particularly high risk of progression to MCI and/or dementia due to Alzheimer’s disease.

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    Efficacy and Safety of T-817MA in patients with mild to moderate Alzheimer’s Disease

    The primary objective is to evaluate the efficacy of T-817MA, a research medication being tested to see if it improves the symptoms in patients with Alzheimer’s disease. Outcome measures include the ADAS-cog and ADCS-CGIC. Efficacy, safety and tolerability will be monitored.

    Efficacy, Safety and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer’s Type

    Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.

    This is a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment.

    Approximately 380 participants will be enrolled at approximately 60 centers in North America.

    Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening must occur within 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

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    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.

    Registry of Amyloid Positive Patients for Alzheimer’s Disease Drug Research Trials (RAmP)

    This registry will be used to identify patients who have etiology diagnosed or suspected to be Alzheimer’s disease and positive amyloid scans, and have indicated their interest in being contacted for an Eli Lilly and Company (Lilly) Alzheimer’s Disease drug research trial.

    Study Population
    Patients who have a) objectively verified cognitive impairment and etiology diagnosed or suspected to be Alzheimer’s disease and b) a willingness to make available to Avid a preexisting amyloid scan that has been interpreted as positive, or if an amyloid scan is not available, a willingness to undergo amyloid scanning via the Florbetapir F 18 PET Scan Addendum, will be enrolled.
    Inclusion Criteria:
    • Male or female patients ≥ 50 years of age at the time of consent;
    • Patients who have objectively verified cognitive impairment and etiology diagnosed or suspected to be Alzheimer’s disease;
    • Patients who are willing to make available to Avid a positive amyloid scan, or if an amyloid scan is not available, are willing to undergo amyloid scanning via the Florbetapir F 18 PET Scan Addendum;
    • Patients who are willing to be contacted for possible participation in Lilly drug research trials targeting Alzheimer’s disease;
    • Patients who give informed consent or have a legally authorized representative (LAR) to consent for enrollment; and
    • Patients who have a partner (informant) who is willing to participate as a source of information and has at least weekly contact with the patient (contact can be inperson, via telephone or electronic communication). The informant must have sufficient contact such that the referring physician feels the informant can provide meaningful information about the patient.

    Exclusion Criteria:

    • Patients who have a Mini Mental State Examination (MMSE) score of < 10;
    • Patients who have an amyloid-negative PET scan (either a historical scan or scan via the Florbetapir F 18 PET Scan Addendum);
    • Patients who have serious or unstable medical conditions that would exclude completion of all procedures and data collection for the registry, or would be likely to preclude participation in a drug research trial;
    • Patients who have participated in a clinical trial investigating an anti-amyloid agent;
    • Patients who are currently participating in a clinical trial with an investigational agent; or
    • Patients who, in the opinion of the physician, are otherwise unsuitable for this registry.

    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.