The guide to
Clinical Trials for Alzheimer's
Types of trials
How trials work
Things to consider
What's a clinical trial?
Want to get involved in Alzheimer's or dementia research? First, you'll want to understand how clinical studies work.A clinical study may be an observational or interventional research involving human volunteers, intended to add to medical knowledge.
Observational studies
Interventional trials
Return
Next
How do observational studies work?
Sleep meds and dementia risk
In 2019, UCSF researchers studied non-dementia adults aged 70-79. Over 15 years, they found that Caucasian men who took sleeping meds "often" or "almost always" were more likely to develop dementia than "never" or "rarely" users.
Read more
Return
Next
How do interventional trials work?
Depending on the type of trial, researchers are looking for people who have a diagnosis already, who carry a certain gene, or who just want to help accelerate research using their healthy brain. By following the requirements of the study and documenting their health status, participants generate valuable data that can lead to new ways to diagnose, treat, or mitigate dementia. The following are some common types of interventional trials:
Prevention Trials
Diagnostic Trials
Lifestyle Trials
Drug Trials
Return
Next
FAQ about trial participation
In trials that test new drugs or treatments, participants are randomly assigned into two groups. Those in the test group receive the experimental treatment, and those in the control group receive a placebo instead.
Participants
Test group
Control group
Return
Next
What if I'm in the control group?
Being in the control group doesn't mean you'll be denied access to new treatments. If the trial succeeds and the treatment is approved, control group participants usually get priority access to the new treatment.
Can I request to be in the test group?
No. Medical trials are double-blind, which means neither the participants or researchers know which group the participants are in until the trial ends.
Return
Next
Drug trials typically have three phases
Trials move on to next phase with more volunteers if the previous phase is successful
Phase 1
Phase 2
Phase 3
Confirm effectiveness and compare to current treatments
Test for safety and side effects
Test for effectiveness
Purpose
Number of volunteers
~20-80
~100-300
~300-3,000
From months to 2 years
Up to 1 year
Multiple years
Duration
Return
Next
What do participants say about their experience?
Meet Debra and Chris Tann
Chris Tann, a Navy veteran and dementia advocate, was diagnosed with behavioral variant frontotemporal dementia in 2019. He and his wife, Debra, spoke with Being Patient about why it’s important to participate in trials.
“Chris and I always say clinical research is essential...We tout them [clinical trials] because we know how significant they are. Our bottom line: Yes, we are participating and we are strong proponents for clinical research because if it doesn’t serve us, it's going to serve many others. We’re excited about the idea of contributing to the space in this manner.”
Debra Tann
Read more
Return
Next
Meet Robin McIntyre
Robin McIntyre learned at age 29 that she carries the gene for early-onset Alzheimer’s disease. McIntyre spoke with Being Patient about the time commitment involved in participating in a clinical trial.
“It is [time-consuming]. You have an annual visit where you go to your study site, and that’s usually about a four-day visit where you have a series of two to four PET scans, an hour-long MRI, a lumbar puncture, neuropsychological testing, and physical blood work. You then have to have quarterly safety MRIs. And then as far as dosing goes, for me, [it’s] bimonthly. Every two weeks, a nurse comes to my house to do an infusion. And those visits usually take anywhere from four to eight hours, so that’s a whole day’s [worth of] work missed, twice a month, unless you’re doing them on weekends. It’s quite a commitment.”
Robin McIntyre
Read more
Return
Next
Before deciding to participate in clinical research trials it’s also important to consider some key factors:
Am I eligible? (age, disease status)
Is it logistically feasible?
What would you have to do?
What is the time commitment?
Return
Next
Want to learn more about dementia studies that might be a fit for you?
Subscribe to Being Patient’s Trials Update, a free quarterly newsletter with the latest news on trials.
Every edition includes a list of trials actively recruiting, real stories from clinicaltrial participants, and updates on the pipelines of different dementia drugs.
Subscribe here
Return
Next
Explore more at Being Patient:
How Do Alzheimer’s Clinical Trials Work? And Other FAQs
Pros and Cons: 4 Patients Open Up About Participating in Alzheimer’s Clinical Trials
Considering Enrolling in a Dementia Clinical Trial? 6 Things You Should Know
Return
Next
Want to keep learning?
Visit
beingpatient.com
for the latest news and information on brain health and Alzheimer's disease
Return
Observational studies
Observational studies aim to find out what happens to people in different situations. In an observational trial, you can maintain your current lifestyle and continue existing medical treatments, if any.
Prevention Trials
Prevention trials test different methods for preventing Alzheimer's.Brigham and Women's Hospital conducted a trial for Protollin, an Alzheimer's nasal vaccine. Sixteen early-stage Alzheimer's patients aged 60 to 85, with beta-amyloid plaque buildup in their brains, received the vaccine and were monitored for six months to evaluate dosing and safety.
Read more
Diagnostic Trials
Diagnostic trials aim to validate new testing methods for Alzheimer’s. Koronyo-Hamaoui, a professor at Cedars-Sinai Medical Center, is currently developing retinal scans for Alzheimer’s disease. “The retina is the only central nervous system organ not shielded [by a] bone that can be imaged directly and repeatedly,” he said. This makes retinal scans suitable for detecting neurological issues in the brain.
Read more
Interventional trials
Interventional trials aim to find out more about a particular intervention or treatment. People are randomized into different treatment groups. This is so that the research team can compare the results.
What is the time commitment?
Clinical trials can take months or even years to complete, so you ought to make sure you can commit to the study for its full duration.
What would you have to do?
You should understand the purpose of the trial, which affects whether you have to change your lifestyle, undergo tests, or take experimental drugs.
Am I eligible?
Trials often require people of a certain age, or those at a certain stage of the disease. Therefore, you should check that you meet the inclusion criteria for the trial you are interested in.
Lifestyle Trials
Lifestyle trials aim to understand how changes in lifestyle (e.g., diet, exercise, and other habits) impact brain health.In 2020, researchers from German Sport University Cologne ran a lifestyle trial on daily exercise and dementia. They found evidence that a specialized exercise program may help ease symptoms of depression and anxiety in people living with dementia.
Read more
Is it logistically feasible?
Because trials may require regular check-ups or tests, it is often recommended that you join trials that are conducted at nearby locations, and a care partner may be needed.
Drug Trials
Drug trials study the safety and effectiveness of potential drugs to prevent or treat Alzheimer's. Eli Lilly's donanemab, a drug targeting amyloid plaques in the brain, was approved in July 2024. Its trial revealed that the drug lowered amyloid burden in a significant number of patients within six months, and around half within twelve months.
Read more
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Transcript
The guide to
Clinical Trials for Alzheimer's
Types of trials
How trials work
Things to consider
What's a clinical trial?
Want to get involved in Alzheimer's or dementia research? First, you'll want to understand how clinical studies work.A clinical study may be an observational or interventional research involving human volunteers, intended to add to medical knowledge.
Observational studies
Interventional trials
Return
Next
How do observational studies work?
Sleep meds and dementia risk
In 2019, UCSF researchers studied non-dementia adults aged 70-79. Over 15 years, they found that Caucasian men who took sleeping meds "often" or "almost always" were more likely to develop dementia than "never" or "rarely" users.
Read more
Return
Next
How do interventional trials work?
Depending on the type of trial, researchers are looking for people who have a diagnosis already, who carry a certain gene, or who just want to help accelerate research using their healthy brain. By following the requirements of the study and documenting their health status, participants generate valuable data that can lead to new ways to diagnose, treat, or mitigate dementia. The following are some common types of interventional trials:
Prevention Trials
Diagnostic Trials
Lifestyle Trials
Drug Trials
Return
Next
FAQ about trial participation
In trials that test new drugs or treatments, participants are randomly assigned into two groups. Those in the test group receive the experimental treatment, and those in the control group receive a placebo instead.
Participants
Test group
Control group
Return
Next
What if I'm in the control group?
Being in the control group doesn't mean you'll be denied access to new treatments. If the trial succeeds and the treatment is approved, control group participants usually get priority access to the new treatment.
Can I request to be in the test group?
No. Medical trials are double-blind, which means neither the participants or researchers know which group the participants are in until the trial ends.
Return
Next
Drug trials typically have three phases
Trials move on to next phase with more volunteers if the previous phase is successful
Phase 1
Phase 2
Phase 3
Confirm effectiveness and compare to current treatments
Test for safety and side effects
Test for effectiveness
Purpose
Number of volunteers
~20-80
~100-300
~300-3,000
From months to 2 years
Up to 1 year
Multiple years
Duration
Return
Next
What do participants say about their experience?
Meet Debra and Chris Tann
Chris Tann, a Navy veteran and dementia advocate, was diagnosed with behavioral variant frontotemporal dementia in 2019. He and his wife, Debra, spoke with Being Patient about why it’s important to participate in trials.
“Chris and I always say clinical research is essential...We tout them [clinical trials] because we know how significant they are. Our bottom line: Yes, we are participating and we are strong proponents for clinical research because if it doesn’t serve us, it's going to serve many others. We’re excited about the idea of contributing to the space in this manner.”
Debra Tann
Read more
Return
Next
Meet Robin McIntyre
Robin McIntyre learned at age 29 that she carries the gene for early-onset Alzheimer’s disease. McIntyre spoke with Being Patient about the time commitment involved in participating in a clinical trial.
“It is [time-consuming]. You have an annual visit where you go to your study site, and that’s usually about a four-day visit where you have a series of two to four PET scans, an hour-long MRI, a lumbar puncture, neuropsychological testing, and physical blood work. You then have to have quarterly safety MRIs. And then as far as dosing goes, for me, [it’s] bimonthly. Every two weeks, a nurse comes to my house to do an infusion. And those visits usually take anywhere from four to eight hours, so that’s a whole day’s [worth of] work missed, twice a month, unless you’re doing them on weekends. It’s quite a commitment.”
Robin McIntyre
Read more
Return
Next
Before deciding to participate in clinical research trials it’s also important to consider some key factors:
Am I eligible? (age, disease status)
Is it logistically feasible?
What would you have to do?
What is the time commitment?
Return
Next
Want to learn more about dementia studies that might be a fit for you?
Subscribe to Being Patient’s Trials Update, a free quarterly newsletter with the latest news on trials.
Every edition includes a list of trials actively recruiting, real stories from clinicaltrial participants, and updates on the pipelines of different dementia drugs.
Subscribe here
Return
Next
Explore more at Being Patient:
How Do Alzheimer’s Clinical Trials Work? And Other FAQs
Pros and Cons: 4 Patients Open Up About Participating in Alzheimer’s Clinical Trials
Considering Enrolling in a Dementia Clinical Trial? 6 Things You Should Know
Return
Next
Want to keep learning?
Visit
beingpatient.com
for the latest news and information on brain health and Alzheimer's disease
Return
Observational studies
Observational studies aim to find out what happens to people in different situations. In an observational trial, you can maintain your current lifestyle and continue existing medical treatments, if any.
Prevention Trials
Prevention trials test different methods for preventing Alzheimer's.Brigham and Women's Hospital conducted a trial for Protollin, an Alzheimer's nasal vaccine. Sixteen early-stage Alzheimer's patients aged 60 to 85, with beta-amyloid plaque buildup in their brains, received the vaccine and were monitored for six months to evaluate dosing and safety.
Read more
Diagnostic Trials
Diagnostic trials aim to validate new testing methods for Alzheimer’s. Koronyo-Hamaoui, a professor at Cedars-Sinai Medical Center, is currently developing retinal scans for Alzheimer’s disease. “The retina is the only central nervous system organ not shielded [by a] bone that can be imaged directly and repeatedly,” he said. This makes retinal scans suitable for detecting neurological issues in the brain.
Read more
Interventional trials
Interventional trials aim to find out more about a particular intervention or treatment. People are randomized into different treatment groups. This is so that the research team can compare the results.
What is the time commitment?
Clinical trials can take months or even years to complete, so you ought to make sure you can commit to the study for its full duration.
What would you have to do?
You should understand the purpose of the trial, which affects whether you have to change your lifestyle, undergo tests, or take experimental drugs.
Am I eligible?
Trials often require people of a certain age, or those at a certain stage of the disease. Therefore, you should check that you meet the inclusion criteria for the trial you are interested in.
Lifestyle Trials
Lifestyle trials aim to understand how changes in lifestyle (e.g., diet, exercise, and other habits) impact brain health.In 2020, researchers from German Sport University Cologne ran a lifestyle trial on daily exercise and dementia. They found evidence that a specialized exercise program may help ease symptoms of depression and anxiety in people living with dementia.
Read more
Is it logistically feasible?
Because trials may require regular check-ups or tests, it is often recommended that you join trials that are conducted at nearby locations, and a care partner may be needed.
Drug Trials
Drug trials study the safety and effectiveness of potential drugs to prevent or treat Alzheimer's. Eli Lilly's donanemab, a drug targeting amyloid plaques in the brain, was approved in July 2024. Its trial revealed that the drug lowered amyloid burden in a significant number of patients within six months, and around half within twelve months.
Read more