A Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Participants With Preclinical Alzheimer’s Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid
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 seeks to recruit adults ages 55 to 80 who show elevated amyloid but have not manifested symptoms of Alzheimer’s disease. Participants will be tracked throughout 4 years of treatment. Click here to learn more about the AHEAD Study.
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.
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 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)
Green Valley is a phase 3 double-blind study that evaluates the efficacy and safety of sodium oligomannate in patients with mild to moderate Alzheimer’s disease. Sodium oligomannate (GV-971) is a large molecule derived from seaweed. GV-971 may aid the gut bacteria which live in our GI system. It may decrease abnormal gut bacterial compounds and reduce peripheral inflammation. It may change neuroinflammation in the brain. The drug is approved in China, but not in the US. This clinical trial takes place over 90 weeks and is currently enrolling.
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.
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.
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.