Ready to shine a new light on Alzheimer’s disease? Consider joining this research study!
ABOUT THE SHINE STUDY
The SHINE research study is evaluating the study drug, CT1812, in adults who have been diagnosed with mild to moderate Alzheimer’s disease (AD).
AM I ELIGIBLE?
STUDY LOCATIONS
WHO IS ELIGIBLE TO PARTICIPATE IN THIS STUDY?
You or a Loved One May Qualify if You or They:
- Are between the ages of 50 to 85
- Have been diagnosed with mild to moderate AD
- Have a caregiver/study partner who is willing and able to attend all study visits and participate in some study assessments
- Have not had a history of cancer within the last 3 years of screening
There are additional study requirements to participate. A SHINE study representative will discuss them with you.
ABOUT THE STUDY
The SHINE study is evaluating the study drug, CT1812, in adults ages 50 to 85 who have been diagnosed with mild to moderate AD.
The purpose of this research study is to learn about the safety of CT1812 and how well you or your loved one tolerate(s) a once-a-day dose of CT1812. The study will also test how well CT1812 will treat mild to moderate AD.
Up to 144 participants will be enrolled in the SHINE study.
Subjects will be randomly assigned to 1 of the 3 groups in this study:
Group 1: Will take 100 mg of CT1812 (2 capsules) once daily
Group 2: Will take 300 mg of CT1812 (2 capsules) once daily
Group 3: Will take the placebo (2 capsules) once daily
STUDY DURATION
Each participant and caregiver will take part in a screening period of up to 42 days, followed by a double-blind treatment period of 182 days (approximately 6 months) and a follow-up visit at Day 210.
ABOUT THE STUDY DRUG CT1812
The study drug, CT1812, is being investigated for the treatment of AD. The purpose of this research study is to learn about the safety and efficacy of CT1812 and how well the body tolerates a once-a-day dose of CT1812. The study will also test how well CT1812 will treat mild to moderate AD.
CT1812 is a capsule taken every morning by mouth with food and approximately 240 mL (1 cup) of water. This study drug will be compared to a placebo. A placebo is a capsule that looks identical to the study drug but does not contain any active ingredient.
In this research study, participants have a 66.6% chance of receiving the study drug CT1812 versus the placebo.
Certain proteins (called amyloid beta oligomers) are believed to bind to brain cells in patients with AD, leading to memory problems and confusion. CT1812 is intended to enter the brain and block these proteins from attaching to brain cells. It is hoped that by blocking these toxic proteins from binding to brain cells, patients with AD will experience improved cognitive function. This type of drug is considered disease-modifying, as it may treat the underlying cause of the condition, not just treat the symptoms.
Participants in the study will receive 100 mg of CT1812, 300 mg of CT1812, or placebo once daily for 6 months. In Phase 1 studies, CT1812 was shown to be safe and well tolerated.
WHAT TO EXPECT DURING THE SHINE STUDY
INFORMED CONSENT
To participate in the SHINE study, participants and their caregivers/study partner will be asked to read and sign an Informed Consent Form (ICF). The form explains:
- The purpose of the study
- Required study visits and procedures
- Potential risks and benefits of participation
- Confidentiality
- How participant and caregiver personally identifiable information will be used
- Information on how to withdraw from the study
VISIT PROCEDURES
As safety is the top priority of the SHINE study, all participants will be monitored and supported by the study team. Procedures to ensure the safety and well-being of all participants will be required throughout the SHINE study. Some of the safety procedures include:
- Medical Medication History
- Vital Signs
- Measurement of Body Weight
- Physical Examinations
- Blood and Urine Sample Collections
- Electrocardiogram (ECG)
- MRI
- Amyloid PET Scans
- Genotyping of the Apolipoprotein E (ApoE) Genotype Associated with the Risk and Age of Onset AD
- Mental Health Questionnaires
- Lumbar Punctures
WHY PARTICIPATE IN THE STUDY?
Information from this study may help doctors learn more about treatments for you or your loved one’s condition, as well as other individuals with this disease. Participation could play an integral role in the advancement of AD research.
WHAT IS ALZHEIMER’S DISEASE (AD)?
Alzheimer’s disease (AD) is a progressive brain disorder that slowly destroys memory and other important mental functions due to the age-related buildup of toxic proteins in the brain. This disease causes the brain to shrink and brain cells to die. It is the most common type of dementia that affects memory, thinking, and behavior. Worsening over time, individuals eventually are unable to perform simple daily tasks.
Early-Stage AD (Mild) Symptoms May Include:
- Person may function independently (may still drive, work, and be part of social activities)
- Memory loss
- Taking longer to complete normal daily tasks
- Repeating questions
- Wandering and getting lost
- Losing things or misplacing them in odd places
- Mood and personality changes
- Common difficulties include:
- Coming up with the right word or name
- Remembering names when introduced to new people
- Having difficulty performing tasks in social or work settings
- Forgetting material that was just read
- Losing or misplacing a valuable object
- Experiencing increased trouble with planning or organizing
Middle-Stage AD (Moderate) Symptoms May Include:
- Increased memory loss and confusion
- Being forgetful of events or personal history
- Difficulty with language and problems with reading, writing, and working with numbers
- Shortened attention span
- Problems recognizing family and friends
- Feeling moody or withdrawn, especially in socially or mentally challenging situations
- Having trouble controlling their bladder and bowels
- Experiencing changes in sleep patterns, such as sleeping during the day and becoming restless at night
- Showing an increased tendency to wander and become lost, especially in the late afternoon or evening
- Demonstrating personality and behavioral changes, including suspiciousness and delusions or compulsive, repetitive behavior like hand-wringing or tissue shredding
COMMON QUESTIONS
What is a study drug?
A study drug is not yet approved for sale by any government health agency or authority. Clinical research studies (or trials) are used to test the safety and efficacy of a study drug.
What is a research study?
A research study is designed to evaluate whether a study drug is safe and effective for use in humans. Every study drug goes through the research study process. Participants are given specific medical treatments and researchers closely monitor the results to help determine if the study drug should be approved for wider use. Participants play a very important role in advancing medicine for present and future generations.
What is a placebo?
A placebo is often similar in appearance to the study drug but does not contain any active ingredients. In this study, the placebo does not contain active ingredients and will be identical in appearance to the study drug capsule.
Will compensation be provided to participants?
Study-related therapies and assessments will be provided at no cost. Participants will not be paid to take part in this study; however, study-related expenses such as travel and time may be reimbursed.
Can participants withdraw from the research study after they’ve started?
You or your loved one’s participation in this study is voluntary. You or they can decide to stop at any time and may still be treated at the facility. The decision whether or not to take part in the study will not affect you or your loved one’s current or future care at the facility.
Tell your study doctor if you or your loved one are thinking about stopping or decide to stop. You should talk to the study doctor about leaving the study before the decision is made so that they can find out if you or your loved one are having any side effects from study treatment, and can explain how to stop safely.
What are the responsibilities while participating in this study?
You and your loved one are asked to follow, without exception, the rules and instructions listed within the Informed Consent for the study. If you do not follow these rules and instructions, you or your loved one may be withdrawn from the study.
In order to provide maximum protection for your health, the study will be under the direct supervision of the study doctor and will be conducted by trained personnel. You or your loved one will need to provide all information about current and past health (medical history) at the Screening Visit and at each Follow-Up Visit, including participation in any other research studies. This information is needed to protect your health.
If you or your loved one have a primary care physician, it is strongly recommended that you inform him/her of your interest to participate in this research study.
What is the length of the SHINE study?
The total duration of participation in the study is approximately 8 months including screening. Each participant and caregiver will take part in a screening period of up to 42 days, followed by a double-blind treatment period of 182 days (approximately 6 months) and a follow-up visit at Day 210.
Why does my caregiver need to attend every visit?
Your caregiver will help you with taking the study medication in between visits and help you report how you’re feeling at each office visit. They will need to attend all study visits and participate in some study assessments.
Who oversees clinical research studies?
To help ensure that a research study is ethical and that participants’ rights are protected, Institutional Review Boards (IRB), Ethics Committees (EC), or Ministries of Health (MOH) review and approve study protocols that detail all aspects of how the study is conducted. There are also teams that monitor the study called Clinical Research Associates; they visit the study sites to ensure the study protocol procedures, research requirements, and country regulations are being followed throughout the study. Health authorities may also inspect the study sites to ensure the safety and rights of the participants in a study and the integrity of the research study goals.
What happens to personal information?
There are security measures to protect personal information. This is to avoid personal information from being lost, used, altered, disclosed, or accessed in any unauthorized way. To protect the identity of the participant, personal study information will be coded (e.g., unique study numbers are assigned to each participant). More information about privacy maintenance will be shared with those who choose to participate in the study.
What is a lumbar puncture?
A lumbar puncture (LP) is also called a spinal tap. This is a low-risk, minimally invasive procedure. The procedure typically takes around 15 minutes to perform, and the most common side effects are mild but temporary headache, pain at the lumbar puncture site, and back discomfort or tenderness. Lumbar punctures are used to obtain a sample of cerebrospinal fluid (CSF), a clear liquid that exists around the brain and spinal cord. CSF holds valuable information related to what is occurring in the brain and is extremely meaningful in research studies. Researchers hope that questions about AD, such as how best to diagnose earlier and more accurately, as well as how effective the study drug is, can be answered by studying each participant’s CSF.
Participants in this research study will need to undergo two lumbar punctures throughout the research study- at the Screening Visit, 24 hours prior to Day 98 Visit (optional) and on Day 182 Visit. Cerebrospinal fluid (CSF) will be collected via a lumbar puncture (LP). A qualified health care professional will perform the LP.
What should you expect during a lumbar puncture?
- LPs are completed in one of two positions. Proper positioning is important and will be explained in detail by the trained healthcare professional completing the procedure. You may either lie down on your side and draw up your knees towards your chest, or you may be seated, leaning forward with your head over your knees.
- Your lower back will be cleaned and sterilized prior to the procedure. A numbing medication (local anesthetic) will be used to numb the tissues of the lower back.
- A thin needle is used to insert between two vertebrae. You may experience some pressure, or what some describe as a “spark” of sensation.
- Once the needle is in place, some of your CSF will be withdrawn, then the needle is removed. Usually a band-aid will be placed on the injection site.
- It is recommended that you rest for most of the day following the procedure and drink a lot of fluids. Strenuous activity should be avoided for 48 hours.
- The most common side effect from an LP is a headache, which is typically mild and temporary. With bedrest and hydration, nearly all headaches resolve within 1 day. Some lower back pain or injection site tenderness may also occur.
How can I learn more about the study drug CT1812 and the SHINE study?
More information about this research study can be found by visiting: ClinicalTrials.gov (NCT03507790)
WHERE WE ARE
STUDY LOCATIONS
Current study locations are listed below and more may be added at any time.
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