I came across this call for participants through the Stanford University Center on Longevity, and thought I would spread the word. They are currently recruiting participants, looking for healthy adults aged 65-83 with no history of cognitive impairment or mental illness. The goal is to investigate the genetic risk of developing dementia (through blood tests) and to investigate the safety and effectiveness of a medication (currently used to control diabetes) in preventing Alzheimer’s Disease.
If you are eligible, you will either take a placebo or the new medication.
From a USA Today article on the study:
Participants are tested for mutations in the apolipoprotein E gene, or APOE-e, which is associated with an increased number of clumps of proteins known as amyloid and tau. These protein clumps, in turn, have been linked to to Alzheimer’s. Researchers also are interested in the gene known as TOMM40, which is believed to interact with APOE-e.
Participants who carry that gene combination will be given either the experimental drug compound pioglitazone or a placebo. Pioglitazone, also known as Actos, is commonly prescribed to help control blood sugar in Type 2 diabetes.
For years, scientists have linked high blood sugar with a greater risk of dementia. Controlling blood sugar may slow a toxic buildup of those proteins.
There is a prescreening link at the bottom of this post, where you can find out if you would be eligible to participate in the study.
The TOMMORROW study seeks to learn more about the genetic risk for developing mild cognitive impairment due to Alzheimer’s disease (MCI due to AD) and whether an investigational medication might prove effective in delaying the early symptoms of this condition.
About the TOMMORROW Study
The TOMMORROW study is a research study seeking to learn more about the earliest stages of Alzheimer’s disease (AD). This study is currently recruiting more than 5,000 healthy senior participants in approximately 50 study centers in North America, Europe, and Australia. The purpose of the study is twofold:
- To study a new investigational test to see if it can predict the genetic risk for developing mild cognitive impairment (MCI) due to AD by examining two specific genes—APOE and TOMM40.
- To test the safety and effectiveness of an investigational medication in delaying the first symptoms of MCI due to AD.
Study Sites in the TOMMORROW Study
The TOMMORROW study is taking place in approximately 50 study centers in North America, Europe, and Australia.
Who is eligible to participate?
To be included in the TOMMORROW study, you must:
- Be 65 to 83 years of age
- Be in good physical and mental health
- NOT have a current diagnosis or history of:
- Cognitive impairment
- Neurological/psychiatric disorders
- Any other diagnosis that significantly affects your cognitive performance (such as mental retardation or a disease-related decline in mental function)
- NOT have a current diagnosis of mental illness
You are also required to have a project partner, such as a spouse, companion, close friend, or adult family member. This person will provide information about your thinking abilities and behavior throughout the study and will need to participate in regular study visits. Other study requirements will be reviewed by site study staff.
What is the role of the project partner?
The project partner is someone in close contact with the study participant who can provide information about the participant’s thinking abilities and behavior throughout the study. The project partner will need to participate in regular study visits (every 6 months for approximately 3-4 hours per visit) as well as answer questions via telephone about the participant’s health and daily functioning approximately every 3 months in between these regular visits (for approximately 15 minutes per call).
What does the study involve?
The TOMMORROW study consists of 3 phases:
- Screening: During this phase, a study doctor will examine you, conduct a medical history, and take a blood test that will examine two specific genes—APOE and TOMM40.
- Active Participation (Dosing Stage): If you qualify for the study, you will receive either the investigational medication or a placebo (look-a-like with no active ingredients, sometimes called a sugar pill). You and your project partner will be required to attend site visits every 6 months for assessments of safety, efficacy, and treatment compliance and to answer questions related to safety and treatment compliance via the telephone every 3 months in between these visits. The total amount of time you may be involved in this study is approximately 5 years.
- Follow-up: At the end of the study, you will receive a physical exam and tests, as well as a follow-up call two weeks after study completion.
Is there any cost to participate in the study?
You do not have to pay for the study medication, study visits, or any tests that are part of the study. Transportation assistance may also be available.
Why should I consider participating?
By volunteering for the TOMMORROW study, you are contributing to a process that may have the potential to help millions of people at risk for developing MCI due to AD. Participating also allows you to:
- Proactively measure your cognitive health
- Contribute to the understanding of how age and genetic factors affect the health of our minds
- Receive study-related medical care from a team of study physicians (in addition to your own family physician)
What is the time commitment involved?
You and your project partner will be required to attend site visits every 6 months for assessments of safety, efficacy and treatment compliance and to answer questions related to safety and treatment compliance via the telephone every 3 months in between these visits. The total amount of time you may be involved in this study is approximately 5 years.
What else should I know about participating in a clinical study?
Like all research studies, the study procedures as well as the investigational medication carry a certain amount of risk. The study doctor can talk to you about side effects people have reported after taking the investigational medication. It is important that you report any and all symptoms or health problems to the study doctor, whether or not you think these problems are related to the investigational medication. Your involvement is completely voluntary and you may choose to leave the study at any time.
Q. Will the medications I currently take interact with the study medication?
A: Potential participants will be carefully screened by study staff prior to participating. You will be excluded from participating if the medications you currently take cannot be taken with the study medication or any of the study procedures. It is always important to alert your doctor and your study team about any new medications you might be prescribed during the study.
Q: Who will care for me during the study? Will I see my regular doctor?
A: During the study, you will be cared for by a team at the study site that includes study doctors, nurses, and other qualified staff. You will continue to see your regular doctor for any personal medical visits that are unrelated to the study.
Q: How far will I need to travel to participate?
A: Please review the map to find the nearest study site. Transportation support may be offered.
Q: Will I be compensated for my participation?
A: There is no compensation for participating in this study; however, you may be reimbursed for your time from the study site. Talk to a participating study site for more information.
Q: Will I receive the results of the genetic blood test?
A: It is important to understand that a portion of this research is designed to help us understand the role of genetics in predicting risk for developing mild cognitive impairment (MCI). The samples you provide will assist us with this research. The results of the blood test are experimental and will not be shared with you or the study physician.
Are you eligible for the TOMMORROW study?
To find out if you may be eligible to participate in the research study, you can take this prescreener questionnaire. You’ll be asked a few questions about your age and general health. Your answers to these questions will help determine if you are a potential candidate for the study. You may stop responding or exit out of the questionnaire at any time.
Your privacy and personal information will be protected. If you qualify for further screening, the information you submit to Hudson Global (the host of this Web site) will be shared with a physician’s office conducting the study.