About Clinical Trials

Whether to participate in a clinical trial is an important and personal decision. Those interested in participating in a clinical trial are encouraged to discuss this opportunity with their physician, family members, or friends before joining a trial. Trial participation is always optional, never required, and free of charge.  Before making a decision, potential participants should be given information about the intervention being studied, the length of study and frequency of visits, and the required procedures.  An opportunity to ask questions of an investigator should also always be provided.  Only when a potential participants have this information and are confident that a trial is right for them, should they choose to enroll.

What is a clinical trial?

A clinical trial is a research study to test if an intervention helps treat or prevents disease in people. Therapies being tested in a clinical trial can be in many forms: vaccines, new pill medications, new devices, new lifestyle or behavioral changes, or new ways of using known therapies.  Clinical trials are used to determine whether new therapies are both safe and effective.

After researchers test new therapies or procedures in animal studies, only the most promising laboratory results are moved into clinical trials with human participants. Clinical trials may be sponsored or funded by a variety of organizations such as the National Institutes of Health (NIH), private foundations,  and pharmaceutical companies.

Who can participate in a clinical trial?

All clinical trials have specific criteria for who may participate. These inclusion and exclusion criteria help ensure safety and are vital to a trial’s scientific aims.  For someone to participate in a clinical trial, they must demonstrate all of the “inclusion criteria” (e.g., be a certain age or have a specific diagnosis).  They must not demonstrate any of the “exclusion criteria” (e.g. have had a stroke or have metal in their body that prevents them from having brain scans).

What are the benefits and risks?

Benefits.  Well-designed and carefully executed clinical trials allow eligible participants to play an active role in their own health care. Participants may gain access to new treatments before they are widely available. Participants also obtain expert medical care at leading health care facilities. Through their participation in studies, participants are helping others by contributing to medical research.

Risks.  There are risks to clinical trials such as adverse reactions to medications or the possibility that the treatment may not be effective for the participant. Some of side effects to the studies may be unpleasant, or even serious reactions.  Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to assure that the risks are minimized and are worth the potential benefits. Many studies require considerable time and effort, including multiple trips to the study site, extensive memory testing, or even complex dosage requirements.

What does it cost to participate?

There should never be a charge to participate in a clinical trial.

Where do the visits take place? 

Most visits take place at our Clinical Translational Research Center in Hewitt Hall on the UC Irvine campus in Irvine.

How long are the visits? 

On average, a visit can last 1-2 hours.

Do I need to stop taking my current medications to participate?

No, you can continue on your current medications. However, many trials require that dosages have been stable for 2 to 4 months prior to enrolling.

Will I receive feedback during the trial?

Some studies provide participants with copies of their clinical lab results, EKG tracings, and brain imaging reports.

Will I be notified about the results of the study?

Most studies provide participants with a summary of results once they are available.  Studies also generally inform participants of their study assignment (study drug vs. placebo) after there is no longer risk of biasing study results.

Will there be compensation for my participation?  

Some studies do provide compensation, but it varies from study to study.

Why should I participate in a clinical trial?  

Most people choose to participate in clinical trials for three reasons: (1) hope to help mankind; (2) trust in the researchers; (3) hope for personal benefit. To learn more about the experiences of UCI MIND research participants, click here.

 Is there a chance of getting a placebo during the trial?  

In most studies, a portion (e.g., 50%) of the participants are given placebo. This varies from study to study and is critical to the scientific aims of a study.

Are there any studies that are not double-blind?

The majority of our studies are double-blind, meaning both the investigator and the participant do not know to which arm of the study the participant is assigned. On some occasions we do conduct open label studies in which all participants receive the actual study medication. These studies, however, are usually restricted to those individuals who previously completed the double-blind, placebo-controlled study of the same medication.

Where can I find out more information about clinical trials?

Click here to see a list of research studies currently enrolling volunteers, or contact our research team at 949.824.0008 or research@mind.uci.edu.

Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Study (A4)

Lead researcher: Aimee L. Pierce, MD

Location: UCI Campus (UCI MIND Gottschalk Medical Plaza, ICTS in Hewitt Hall, Newport Diagnostic Center, CARE Clinic in Laguna Woods)

Purpose: To evaluate whether immunization treatment with solanezumab versus placebo will slow cognitive decline in individuals showing the presence of elevated protein called amyloid on a brain scan

Eligibility: Male and female participants, ages 65 to 85 years old, with evidence of elevated brain amyloid pathology on a brain scan

Time commitment: Screening phase (up to 90 days) and treatment phase (48 visits over the course of 168 weeks or ~3 years)

Benefits: You may or may not receive any benefit from being in this study. If you are in the group that receives the study drug, solanezumab, and it proves to treat your condition better than placebo, you may benefit from participating in the study, but this cannot be guaranteed.  The information collected from this study may increase knowledge regarding the treatment of Alzheimer’s disease and help people in the future.

Compensation:  Participants are eligible to receive the following compensation in cash during the course of this study:

  • $100 for each completed MRI scan; there are 4 MRI scans ($400 max)
  • $100 for each completed PET scan; there are 2 PET scans ($200 max)
  • $100 for each completed lumbar puncture; there are two optional lumbar punctures ($200 max)
  • $50 for each infusion visit requiring infusion; there are 42 infusion visits in this study ($2100 max)
  • Total compensation for this study is a maximum of $2900 in cash
  • Participants will also be reimbursed $40 in cash for travel-related expenses for each visit required for the study

Contact name: Beatriz Yanez, RN
Phone: 949.824.0008
Email: research@mind.uci.edu
Study website: http://a4study.org/

Phase 3 Study of Aducanumab in Early Alzheimer’s Disease (EMERGE)

Lead researcher: Aimee L. Pierce, MD

Location: UCI Campus (UCI MIND Gottschalk Medical Plaza, ICTS in Hewitt Hall, Newport Diagnostic Center)

Purpose: To evaluate the safety and efficacy of an investigational medication to determine whether it can slow the progression of symptoms in early Alzheimer’s disease

Eligibility:

  • 50 to 85 years of age
  • Experiencing symptoms that might be related to early Alzheimers’ disease, such as problems with memory or thinking clearly
  • Have someone who can be your study partner to accompany you to certain appointments and provide information about your health

Time commitment: If you are eligible for the treatment phase, you will receive placebo or the investigational medication and have 32 visits over the course of up to 78 weeks.

Compensation: If eligible, all study medication, examinations, and medical care related to the study will be provided at no cost to you. Reasonable compensation for time and travel may be provided.

Contact name: Beatriz Yanez, RN
Phone: 949.824.0008
Emailresearch@mind.uci.edu

Therapeutic Effects of Exercise in Adults with Amnestic Mild Cognitive Impairment Study (EXERT)

Lead researcher: Aimee L. Pierce, MD

Location: UCI Campus (UCI MIND Gottschalk Medical Plaza, ICTS in Hewitt Hall, Newport Diagnostic Center, Newport Mesa YMCA, Huntington Beach Family YMCA)

Purpose: To evaluate whether 18 months of moderate to high intensity exercise will improve cognition in older adults with Mild Cognitive Impairment (MCI).

Eligibility: Adult participants ages 65 to 89 years old who have been diagnosed with MCI

Time commitment: You will be asked to complete a total of 7 clinic visits over the course of the study and participate in a structured exercise program 4 days a week for 18 months. The total time commitment is 20 months.

Anticipated benefits: You will receive an 18 month membership to the YMCA. Participating in the exercise program may or may not improve your condition. The information collected from this study may increase knowledge regarding the treatment of Alzheimer’s disease and help people in the future.

Compensation: You are eligible to receive the following compensation in cash during the course of this study:

  • $100 for each completed MRI scan; there are 2 MRI scans ($200 max).
  • $75 for each completed lumbar puncture (optional) ($150 max).
  • $75 for completing the baseline clinical visit, $50 for completing the month 12 clinical visit and $25 for completing the month 18 clinical visit ($150 max)
  • Total compensation for this study is a maximum of $500 in cash
  • Participants will not be reimbursed for travel-related expenses

Contact name: Beatriz Yanez, RN
Phone: 949.824.0008
Emailresearch@mind.uci.edu

Study of Nasal Insulin to Fight Forgetfulness (SNIFF)

Lead Researcher: Aimee L. Pierce, MD

Location: UCI Campus (UCI MIND Gottschalk Medical Plaza, ICTS in Hewitt Hall, Newport Diagnostic Center)

Purpose: To evaluate whether insulin, when administered as a nasal spray, improves memory in adults amnestic Mild Cognitive Impairment or early Alzheimer’s disease

Eligibility: Male and female participants, ages 55 to 85 years old and diagnosed with amnestic Mild Cognitive Impairment or Alzheimer’s disease

Time Commitment: 18 months total: treatment phase (twice daily intake of nasal insulin or placebo for 12 months), open label phase (twice daily intake of nasal insulin for 6 months)

Benefits: There is no guarantee of personal benefit from participating in this research study.  All subjects will receive active study drug for a period of 6 months during the open label phase.  Subjects will also receive their blood test results which may reveal more information about their blood sugar, cholesterol, liver function and other related health information.

Compensation: Participants are eligible to receive the following compensation in cash during the course of this study:

  • $25 for each study visit; there are 8 visits ($200 max)
  • $100 for each completed lumbar puncture; there are two lumbar punctures ($200 max)
  • Total compensation for this study is a maximum of $400 in cash

Contact name: Beatriz Yanez, RN
Phone: 949.824.0008
Email: research@mind.uci.edu