Alzheimer’s Trials
AACN is a Phase 3, open-label, 2-arm study investigating amyloid plaque clearance from the brain by Donanemab as compared to Aducanumab in patients with Early Symptomatic Alzheimer’s Disease. Patients are randomly assigned to receive infusions of either Donanemab or Aducanumab, with both groups receiving treatment for 76 weeks to comparatively investigate the drugs. Both Donanemab and Aducanumab have previously demonstrated an ability to reduce brain amyloid and potentially slow cognitive decline due to an association between amyloid levels and symptoms of AD. The sponsor, Eli Lilly, aims to investigate the superiority of Donanemab on the degree of amyloid plaque clearance by looking at PET scan results at different time points throughout the trial.
The AHEAD Study’s is evaluating the investigational medicine BAN2401 or Lecanemab. The primary goal is to help identify ways to prevent Alzheimer’s disease (AD). By testing BAN2401 to see if it can slow the earliest brain changes associated with AD and help to prevent the associated memory loss.
We are looking for:
• Are between 55 and 80 years of age
• Have not been diagnosed with AD or another dementia
• Have a caregiver or study partner who can attend visits with you
The study involves one 1- hour visit wither to Abington Neurological Associates or at home every 2 to 4 weeks.
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer’s Disease (INVOKE-2)
AL002-2 is a phase two randomized controlled trial to evaluate the efficacy and safety of AL002 in participants with early Alzheimer’s Disease. AL002 is an antibody that activated something called the TREM2 receptor. TREM2 tells microglial cells, which are amoeba like white blood cells in the brain to clear up the proteins that cause neurodegenerative disorders like Alzheimer’s disease. We hope that the activation of TREM will clear protein and slow cognitive decline in those treated with AL002.
The APOOLLOE4 Study is evaluating an investigational drug that is designed to slow the progression of Alzheimer’s disease (AD). The study drug, ALZ-801, is a tablet that is taken twice daily.
We are looking for people who:
· Are between 50 and 80 years of age
· Positive for the APOE4/4 gene (genetic testing provided at no cost)
· Accompanied by a caregiver or study partner willing to attend study visits and participate with you.
There are other requirements for taking part in APOLLOE4. The study team will discuss more criteria with you.
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer’s Disease
Phase 1a/2b clinical trial to investigate the safety and tolerability of a drug currently called RO7126209. RO7126209 is the same monoclonal antibody gantenerumab from other trials, but has an added part to cross the blood brain barrier. If more gantenerumab gets into the brain, perhaps we could see more effect. The blood brain barrier is made of tightly packed cells, so many drugs have reduced penetrance into the brain. The shuttle stuck onto gantenerumab may allow it to get into the brain and lower brain amyloid burden. Amyloid is a misfolded, non-functional protein which clumps into plaques. They are believed to play an important role in pathogenesis of Alzheimer’s disease and removing them may help slow the disease progression.
A Randomized, Double-blind, Placebo-controlled Trial of CVL-871 in Subjects With Dementia-Related Apathy
This study is a 20-week trial to determine if the study drug, CVL-871, is safe and effective in subjects with dementia-related apathy. Currently, there are no approved treatments for apathy.
A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease
BAN2401 has been shown to be capable of clearing diffuse amyloid plaques, suggesting that it has the potential to neutralize species that provoke synaptotoxic events and to alter plaque formation in the brain. This study hypothesizes that BAN2401 will be effective at early stages of Alzheimer’s disease prior to significant neurodegeneration caused by amyloid deposits. It is hoped that treatment with BAN2401 and attempts to slow disease progression should be most effective at this early stage. As a site, the clinical research department at Abington Neurological Associates began work on this study in 2013 and is currently in the open-label extension phase. Enrollment is currently closed to new subjects.
Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer’s Disease (AD)
Gantenerumab is the investigational drug for Alzheimer’s disease against the pathologic protein that builds up in Alzheimer’s disease called amyloid. Amyloid is misfolded, non-functional proteins which bind together to make aggregates or plaques. The proteins appear to affect nerve cells involved in cognition and memory. It is hoped a drug that clears amyloid proteins will prevent the disease from getting worse. Graduate is a placebo control trial.
Post-Graduate is an Open Label trial where every participant gets active drug which is open ONLY to individuals already enrolled in Graduate trial.
See Graduate. This is an open label trial and participants will get gantenerumab at higher doses than the Graduate and Post-Graduate studies, ultimately getting weekly injections.
A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer’s Disease (GREEN MEMORY)
The Green Memory Study is researching an investigational medication for people who have been diagnosed with mild to moderate Alzheimer’s disease (AD). The investigational medication is designed to restore the natural balance of bacteria in the gut. Certain bacteria are thought to cause inflammation in the brain and nerves, possibly contributing to AD.
We are looking for people who:
· Are between 50 and 85 years of age
· Have been diagnosed with mild to moderate AD.
Study participants must have a “study partner” who has known them for at least a year, knows them well, and is with them 3 or more days a week. The study partner will need to go with the participant to the study visits.
If you take part, you will be in the study for 86 weeks (a little more than 1.5 years).
The INTERCEPT-AD Trial is evaluating the safety and tolerability of the investigational medicine called ACU193. ACU193 is a monoclonal antibody designed to locate and bind to proteins called “amyloid-beta oligomers” that build up in the brain of people with Alzheimer’s disease (AD). These proteins are thought to be involved in AD symptoms and progression.
We are looking for:
· Are between 55 and 90 years of age
· Have memory problems that might be a sign of cognitive impairment.
· Have a caregiver or study partner who knows you very well, who is willing to assist with participation in the study and can attend study visits with the participant.
The study involves 8 -11 visits, over a maximum time period of about 8 months. Some participants will stay overnight at Abington Neurological Associates for 2 to 4 nights. During the visits, participants will have a safe, caring environment, so caregivers can feel confident their loved ones are being treated with kindness and respect.
MTAE is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study of a drug intended to decrease the pathologic processing of a protein called tau. Participants have MCI or early Alzheimer’s disease. This study will utilize a 76-week common close design and all enrolled participants will remain on double-blind randomized treatment and complete assessments. The maximum duration of treatment is 124 weeks. This study will also assess whether inhibition of OGA and potential reduction in aggregated tau can slow the progression of the disease as assessed by clinical measures and biomarkers of disease pathology and neurodegeneration relative to placebo treatment.
New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study
New IDEAS looks at amyloid PET scans and patient-centered outcomes in a diverse group of Medicare participants with cognitive impairment. The investigators of New IDEAS aim to compare outcomes in amyloid PET-positive versus amyloid PET-negative individuals with MCI and dementia, investigate these associations in subgroups of study participants based on self-identifiers and clinical presentation, and evaluate changes in management between the pre- and post-PET visits in the relevant sub-groups, to test whether benefits in health outcomes are mediated by changes in clinical management.
The PROSPECT-ALZ Clinical Research Study is researching the safety and effectiveness of an investigational medicine that targets the tau protein, a substance in the brain that supports brain neuron structure and helps nutrients travel to different parts of a cell. For people with AD, tau proteins in the brain break down inside neurons and stick to each other, forming tangles that cause neurons to die and block communication from one part of the brain to another. This study will research whether the investigational medicine can slow or prevent these tangles from forming.
We are looking for:
· Are between 60 to 85 years of age
· Have memory loss that has gotten worse over time
· Has a reliable study partner who knows you and is willing to go to appointments with you.
The study involves taking an oral medicine in the form of a pill – either the investigational medicine or placebo – daily. The overall study duration can range from 1 year and 6 months to 2 years and 8 months.
Escitalopram for Agitation in Alzheimer’s Disease (S-CitAD)
S-Citad is a 24-week trial designed to observe the efficacy and safety of escitalopram in combination with a psychosocial intervention (PSI) as treatment for Alzheimer’s patients experiencing agitation. Escitalopram is already approved to treat depression and anxiety. This study is currently enrolling new patients from real world settings such as outpatient and assisted living facilities.
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer’s Disease (TRAILBLAZER-ALZ 2)
Placebo controlled trial looking at a drug called Donanemab, an antibody directed against amyloid. Amyloid is misfolded, non-functional proteins which bind together to make aggregates or plaques. The proteins appear to affect nerve cells involved in cognition and memory. It is hoped a drug that clears amyloid proteins will prevent the disease from getting worse.
The TRAILBLAZER-ALZ 4 trial is researching early symptomatic Alzheimer’s disease (AD) causes a small but noticeable and measurable decline in cognitive skills. It involves problems with memory and thinking ability, behavior, and mood. In AD, changes in the brain can happen 10 to 20 years before symptoms of memory loss and changes in thinking appear. One of those early changes is the buildup of a protein, amyloid, in the form of plaques. Scientists think that by removing these amyloid plaques, it may be possible to slow memory changes.
The TRAILBLAZER-ALZ 4 Study will compare how safe and effective two drugs are at removing amyloid plaque in people with early stages of AD – an investigational medicine and a medicine already FDA-approved to treat this condition. Both the investigational drug and the FDA-approved drug are given through a tiny tube into your vein (called an “infusion). All participants will receive either the investigational drug or the FDA-approved drug.
We are looking for:
· Are between 50 to 85 years of age
· Has memory loss that has gotten worse over time
· Has a reliable study partner who knows you and is willing to go to appointments with you.
The study will last for 2.5 years and you will have up to 26 study appointments.
A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Varoglutamstat (PQ912), which prevents a protein called amyloid from becoming toxic. The study will enroll patients with MCI or early, mild Alzheimer’s Disease (AD) with a Stage Gate to Phase 2B (VIVA[1]MIND). The purpose of this study is to learn more about the safety and effectiveness of the study drug called varoglutamstat which may delay or slow the progression of the symptoms of early Alzheimer’s disease.
Statement of inclusion
Abington Neurological Associates is proud to offer clinical trials investigating potential treatments in AD. Alzheimer’s is a terrible, fatal disease, which currently has no disease modifying treatment, and affects people of all creeds, nationalities and ethnicities. We welcome any individual with Alzheimer’s disease into these trials and will continue to do so. In previous trials, we are pleased to have contributed data from traditionally under-diagnosed and under-studied minority populations. ANA is committed to recruiting subjects until AD is cured.
Joining a trial is a highly personal decision. Aside from long lists of exclusion criteria, trials are not the right fit for everyone or for every family. Culture does play a role in this decision making. We aim to remove the barriers we can.