Alzheimer’s Disease

CLINICAL TRIALS FOR ALZHEIMER’S DISEASE

To inquire about your eligibility to enroll in one of our clinical trials, please email [email protected] or call our clinic’s front office at 713-486-0500 and ask to speak to a research coordinator.

Interventional Research Studies on Alzheimer’s Disease

Investigator-Initiated Clinical Trials/ Collaborative Studies

Home-based Transcranial Direct Current Stimulation (tDCS) for Pain Management in Persons with Alzheimer’s Disease – In collaboration with the Cizik School of Nursing at UTHealth
The purpose of this study is to assess the feasibility and effects of a novel nonpharmacological treatment option for pain management in AD patients

  • Patients in early stages of Alzheimer’s Disease with chronic pain for at least 3 months (3 out of 10 pain scale) are invited to participate
  • Age: 50-90 years
  • Study Partner required
  • 2 visits and 5 consecutive days of tDCS (20 minutes) with real time video monitoring

Principal Investigator: Dr. Brian Ahn, Cizik School of Nursing at UTHealth

Non-Interventional Research Studies on Alzheimer’s Disease

The following studies are not clinical trials (i.e., they do not involve interventions such as investigational drugs), but they do provide valuable information that helps us to improve our diagnostic techniques, our understanding of the processes and etiologies (causes) of neurocognitive disorders, and our ability to treat and prevent these disorders.

As with the interventional trials discussed above, if you are interested in learning more about these studies and whether you are eligible to participate in them, please email [email protected] or call our clinic’s front office at 713-486-0500 and ask to speak to a research coordinator.

UTHealth Neurocognitive Disorders Center – Biobank
The UTHealth NDC Biobank serves as a resource for researchers in the UTHealth System, as well as external collaborators, engaged in studies of neurocognitive and other neurological disorders. The NDC Biobank collects and archives blood samples, urine, cerebrospinal fluid, and oral fluids from adult patients and healthy volunteers visiting the Neurocognitive Disorders Center and the Department of Neurology at UTHealth.

  • All Department of Neurology patients and family members are invited to participate
  • Age: over 18 years
  • Clinic patients and healthy volunteers accepted
  • Single or multiple donations will be accepted

Principal Investigator: Dr. Paul Schulz

New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning Study A Study to Improve Precision in Amyloid PET Coverage and Patient Care
The goal of this study is to evaluate and compare changes in management and health outcomes in amyloid PET-positive versus amyloid PET-negative individuals in a diverse sample of people with Mild cognitive impairment (MCI) and dementia.

  • Participants who meet clinical criteria for Mild cognitive impairment (MCI) or Dementia are invited to participate
  • Participants must have Medicare as their primary health insurance
  • PET scan required
  • 3 visits over 120 day period

Principal Investigator: Dr. Paul Schulz

Investigating a Transmissible Component of Dementia
This purpose of this study is to determine an association between Alzheimer’s Disease (AD) and potential transmission routes.

  • All Department of Neurology patients and family members are invited to participate
  • Age: over 18 years
  • Clinic patients and healthy volunteers accepted
  • One time, self-completed, questionnaire of personal health information and history

Principal Investigator: Dr. Paul Schulz

Individual Differences in Dementia Spousal Caregiver Burden: A Biobehavioral Approach (Project ACT – Caregiver Study) – in collaboration with Rice University
The purpose of this study is to find out more about what impacts the mental and physical health of people who are the caregivers for a spouse with mild to moderate Alzheimer’s Disease and related dementias. It is hoped this could be used to help improve spousal caregivers’ quality of life in the future.

  • Spousal caregivers (married or committed partner for 3 or more years) of mild/moderate AD patients who provide at least 4 hours of care per day for at least 3 months are invited to participate
  • Caregivers with a history of uncontrolled medical illness and steroid use are not eligible to participate
  • 4 visits conducted over 2 years conducted at Rice University
  • Procedures: blood draws, wear a heart rate collection device at visits, answer questionnaires
  • Risks: blood draws may cause pain, bleeding, and/or bruising; questionnaires may contain questions that are sensitive in nature; breach of confidentiality

Principal Investigator: Dr. Christopher Fagundes, Rice University

Project CHROMA – in Collaboration with Rice University
Project CHROMA is interested in learning how creativity helps brain health in older adults in order to develop future interventions to offset disease burden.

  • Patients with MCI or people 70 and older are invited to participate
  • Age: +18 (for individuals diagnosed with MCI) or +70 (for individuals without MCI diagnosis)
  • 2 in-person visits approximately two months apart from each other
    – for each visit, you will complete various health assessments, questionnaires, and an fMRI brain scan.

Principal Investigator: Dr. Christopher Fagundes, Rice University

Occult Epileptic Seizures and Epileptiform Activity in Patients with Alzheimer’s Disease: A Prospective Study Using a Computer-Based Detector, High-Density Electroencephalography and Magnetoencephalography
Patients with Alzheimer’s Disease (AD) are more likely to display epileptiform activity and seizures than normal age-matched controls and those with other dementias. These seizures are associated with greater cognitive decline and decreased survival in AD patients. The purpose of this study is to use magnetoencephalography to gain novel insight into patients with early AD or other memory problems who might have these abnormal brain activities.

  • Age: 18-90 years
  • Study Partner required
  • No history of other neurological condition (i.e. Multiple sclerosis, stroke, Parkinson’s, etc.)
  • Comfortable with being in an enclosed space for 1-2 hours
  • 3-4 visits

Principal Investigator: Dr. Samden Lhatoo

Collaborative Studies with Pharmaceutical Companies
Antibody Trials
Antibodies are a type of protein that bind to “intruders,” such as viruses, and help the body get rid of these foreign substances. While our bodies are capable of creating antibodies on their own, scientists can also develop antibodies in the lab that target certain molecules. In the case of Alzheimer’s Disease, antibodies are being developed that target either amyloid beta fragments or tau proteins, which are believed to be two of the major “culprits” in the pathology of Alzheimer’s Disease. Our current antibody trials include:

Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease (TRAILBLAZER-ALZ2)
The purpose of this study is to assess the effect of donanemab versus placebo on clinical progression in participants with early symptomatic AD

  • Patients with early symptomatic Alzheimer’s Disease are invited to participate
  • Sponsored by Eli Lilly and Company
  • Age: 60-85 years
  • Requires Study Partner
  • Multiple MRIs and PET scans are required
  • Study will last for approximately 2 years

Principal Investigator: Dr. Paul Schulz

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease (AuTAUnomy-ALZ2002)
The purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on cognitive decline

  • Patients with early symptomatic Alzheimer’s Disease are invited to participate
  • Sponsored by Janssen Research and Development
  • Age: 55 to 80 years
  • Requires Study Partner
  • Multiple MRIs and PET scans are required
  • Study will last up to 4.5 year

Principal Investigator: Dr. Paul Schulz