Together we can light the way for Dementia with Lewy Bodies research.

See if you Qualify

ABOUT THE SHIMMER STUDY

The SHIMMER study is evaluating the study drug, CT1812, in adults who have been diagnosed with mild to moderate Dementia with Lewy Bodies (DLB).

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AM I ELIGIBLE?

You may be eligible to participate if you are 50 to 85 years old and have been diagnosed with mild to moderate DLB. Additional study eligibility requirements will apply.
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STUDY LOCATIONS

The SHIMMER study will take place at several clinical sites. Click here to view our map and find a participating site location near you.
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 Dementia with Lewy Bodies (DLB)
  • 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 stroke or transient ischemic attack (TIA) within the past 12 months

There are additional study requirements to participate. A SHIMMER study representative will discuss them with you.

ABOUT THE STUDY

The SHIMMER study is evaluating the study drug, CT1812, in adults ages 50 to 85 who have been diagnosed with mild to moderate DLB.

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 oral dose of CT1812. The study will also test how well CT1812 will treat mild to moderate DLB.

Up to 120 participants will be enrolled in the SHIMMER study.

If you take part in the clinical study, your caregiver must accompany you to all your visits, help you with taking the study medication in between visits, and help you report how you are feeling at each visit.

Participants 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*

*A placebo is a capsule that looks identical to the study drug but does not contain any active ingredient. To ensure fairness, neither you nor the study doctor will know whether you or your loved one are receiving CT1812 or placebo.

STUDY DURATION

The total duration of participation in the study is approximately 8 months, including screening. Each participant and caregiver will be required to attend a total of 12 site visits throughout the duration of this study.

Each participant and caregiver will take part in a Screening Visit up to 42 days prior to receiving your first dose, followed by a Double-blind Treatment Period* of 182 days (approximately 6 months) and a Follow-up Visit at Day 210.

*Double-blind Treatment Period is a type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over.

ABOUT THE STUDY DRUG CT1812

The study drug, CT1812, is being investigated for the treatment of DLB. CT1812 is a capsule taken every morning by mouth with food. 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 2 out of 3 chance of receiving the study drug CT1812 versus the placebo.

Certain proteins (called amyloid beta oligomers and α-synuclein oligomers) are believed to bind to brain cells in patients with DLB, 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 DLB will experience improved cognitive function or not have the same rate of decline. This type of drug is considered disease-modifying, as it may treat the underlying cause of the condition, not just treat the symptoms.

In early trials, CT1812 was shown to be safe and well tolerated.

WHAT TO EXPECT DURING THE SHIMMER STUDY

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INFORMED CONSENT

To participate in the SHIMMER 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 SHIMMER 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 SHIMMER study. Some of the safety procedures include:

  • Medical and Medication History
  • Vital Signs
  • Measurement of Body Weight
  • Physical Examinations
  • Blood and Urine Sample Collections
  • Electrocardiogram (ECG)
  • MRI
  • Apolipoprotein E (ApoE) Genotyping
  • Cognitive Measures
  • Mental Health Questionnaires

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. Your participation could play an integral role in the advancement of DLB research.

WHAT IS DEMENTIA WITH LEWY BODIES (DLB)?

Dementia with Lewy Bodies (DLB) is one of the most common causes of dementia. DLB, together with Parkinson’s disease dementia (PDD), is a form of Lewy Body Dementia (LBD). Approximately 1.4 million Americans suffer from LBD, making it the second most common cause of neurodegenerative dementia after Alzheimer’s disease (AD). In addition to progressive dementia and motor deficits, patients with DLB endure a wide range of debilitating symptoms including cognitive fluctuations, recurrent visual hallucinations, and sleep disorders. DLB patients have a shortened lifespan and rapid cognitive decline compared to AD and PDD patients. As a result, DLB is also associated with greater healthcare costs and caregiver burden than other forms of dementia. Unfortunately, no treatments are available to cure or slow the progression of DLB, making disease-modifying therapies for DLB a critical unmet medical need.

A hallmark of DLB is the accumulation of abnormal protein clumps called Lewy Bodies. Lewy Bodies are primarily composed of α-synuclein fibrils and oligomers. Although the processes by which these protein clumps form and spread through the brain are poorly understood, it is widely thought that the accumulation is linked to synaptic dysfunction, neurodegeneration, and neuronal death.

Symptoms of Lewy Body Dementia include:

  • Changes in thinking and reasoning
  • Confusion and alertness that varies significantly from one time of day to another or from one day to the next
  • Slowness, gait imbalance, and other Parkinsonian movement features
  • Well-formed visual hallucinations
  • Delusions
  • Trouble interpreting visual information
  • Sleep disturbances
  • Memory loss that may be significant but less prominent than in Alzheimer’s disease
  • Changes in body temperature
  • Problems with blood pressure
  • Dizziness
  • Fainting
  • Frequent falls
  • Sensitivity to heat and cold
  • Urinary incontinence
  • Constipation
  • Poor sense of smell

Movement Problems and Lewy Body Dementia:

  • Some people with LBD may not experience significant movement problems for several years. Others may experience them early on. At first, movement symptoms, such as a change in handwriting, may be very mild and easily overlooked.
  • Movement problems may include:
    • Muscle rigidity or stiffness
    • Shuffling walk, slow movement, or frozen stance
    • Tremor or shaking, most commonly at rest
    • Balance problems and repeated falls
    • Stooped posture
    • Loss of coordination
    • Smaller handwriting than was usual for the person
    • Reduced facial expression
    • Difficulty swallowing
    • Weak voice

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 effectiveness 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 have 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 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 is thinking about stopping or decides 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 is 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 all study visits including participation in any other research studies. This information is needed to protect your health.

If you or your loved one has 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 SHIMMER study?

The total duration of participation in the study is approximately 8 months, including screening and follow up. Each participant and caregiver will take part in a Screening Visit (to see if you qualify) up to 42 days prior to receiving your first dose, followed by a Double-blind Treatment Period* of 182 days (approximately 6 months) and a Follow-Up Visit around Day 210. Each participant and caregiver will be required to attend a total of 12 site visits throughout the duration of this study.

*Double-blind Treatment Period is a type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over.

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 are 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) and the U.S. Food and Drug Administration (FDA), 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?

Participants in this research study can opt-in to undergo two lumbar punctures during the research study – during the Screening period and on 24 hours prior to Day 182 Visit. Cerebrospinal fluid (CSF) will be collected via a lumbar puncture (LP). A qualified health care professional will perform the LP. If participants do not wish to participate in this optional part of the study, they may still participate in the rest of the study.

A lumbar puncture (LP) is also called a spinal tap. The term lumbar refers to the lower back area of the spine. 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 DLB, 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.

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 health care 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 SHIMMER study?

More information about this research study can be found by visiting: ClinicalTrials.gov (NCT05225415)

WHERE WE ARE

STUDY LOCATIONS

Current study locations are listed below and more may be added at any time. If you or your loved one is interested in participating in the SHIMMER study, complete the form to speak with a study representative regarding eligibility and available study locations.

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