Research trials

Why participate in research

By being part of a clinical trial, you have the potential to help both yourself and future generations who may be at risk for Alzheimer's disease. Many patients feel that being part of a clinical trial allows them to play a more active role in their healthcare.

Clinical trials increase our understanding about a disease and is how all new treatments are developed and demonstrated to be safe and effective. The first patient to be cured of Alzheimer's disease will likely be in a clinical trial. By being part of a clinical trial, you can help to make a difference.

Positive aspects of research:

• Combat the feeling of helplessness by contributing to the prevention or treatment of a disease.
• Learn more about your disease.
• Gain access to new treatments before they are widely available.

Challenges of research:

• Some studies require a significant time commitment.
• There are likely to be strict requirements for joining a study, so you may not be able to participate in some studies.
• Many studies randomly assign participants to receive the study drug or a placebo (inactive substance), and you will not know which group you have been assigned to until the very end of the study.

Current clinical trials

U.S. POINTER healthy lifestyle study

Clinical Trial Title: U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (POINTER)

Clinical Trial ID: Clinicaltrials.gov: NCT03688126

Site Principal Investigator: Darren Gitelman, MD

Study description:
The purpose of this research study is to see if lifestyle changes can protect memory and thinking (cognition) as we age. A recent study in Finland found that a combination of physical and cognitive exercise, diet, and social activity protected cognitive function in healthy older adults who were at increased risk of significant memory loss. So far, no medications can rival this positive outcome. The point of POINTER is to test if lifestyle change can also protect against memory loss in Americans.

Some eligibility criteria:
Eligible participants include people who:

• Are 60 to 79 years of age.
• Do not exercise regularly.
• Have no current memory problems.
• Have a parent or sibling with a history of memory problems and/or have certain medical conditions such as high blood pressure, high cholesterol or diabetes.
• Live within a study recruitment area.

You will not be able to participate if you:

• Already have memory impairment.
• Are exercising regularly and vigorously.
• Have a medical condition that would interfere with regular exercise.

This is only a partial list of eligibility criteria.

Learn more about U.S. POINTER at uspointer@aah.org or 847-720-6467.

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Dominantly Inherited Alzheimer's Network – Trials Unit

Clinical Trial Title: Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease-Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. (DIAN-TU)

Clinical Trial ID: Clinicaltrials.gov: NCT01760005

Site Principal Investigator: Darren Gitelman, MD

Study description:
The overall purpose of this study is to assess the safety, tolerability, biomarker status and cognitive efficacy of investigational products in people who are known to have an Alzheimer's disease-causing mutation, in order to determine if treatment with the study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers.

Currently the study is enrolling participants for cognitive testing and brain imaging (Cognitive Run-In). These subjects will be the first ones eligible for participation in the next drug treatment group.

Some eligibility criteria:
Eligible participants include people who:

• Are between 18-80 years of age.
• Know they have an Alzheimer's disease-causing mutation or are unaware of their genetic status but know (or suspect) they have an autosomal dominant Alzheimer's disease (ADAD) mutation in their family.
• Are cognitively normal or have mild cognitive impairment or mild dementia.

You will not be able to participate if you:

• Have other clinical significant neurological or medical conditions.
• Are unable or unwilling to have magnetic resonance imaging scans, PET scans or lumbar puncture tests.

This is only a partial list of eligibility criteria.

Learn more about DIAN-TU at megon.holldorf@aah.org or 847-723-7625.

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Refocus ALZ

Clinical Trial Title: Simufilam 50 mg or 100 mg for Mild to Moderate Alzheimer's Disease (REFOCUS-ALZ)

Clinical Trial ID: Clinicaltrials.gov: NCT05026177

Site Principal Investigator: Darren Gitelman, MD

Study description:
A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild to moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1,083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam twice daily for 76 weeks. Clinic visits will occur four weeks after the baseline visit and then every 12 weeks until the end of the study. The safety of simufilam and its efficacy.

Some eligibility criteria:
Eligible participants include people who:

• Are 50 to 87 years old
• Meet National Institute on Aging and Alzheimer’s Association Research Framework criteria for individuals in clinical Stage 4 or 5 of the Alzheimer’s continuum
• Have evidence of AD pathophysiology, confirmed prior to or during screening

You will not be able to participate if you have:

• A neurologic condition other than AD that significantly contributes to the subject’s dementia
• Any current primary psychiatric diagnosis other than AD if it is likely to confound cognitive assessment or ability to comply with study procedures

This is only a partial list of eligibility criteria.

Learn more about Refocus ALZ at samuel.streeter@aah.org or 847-723-8927.

Find out more about becoming a research participant.