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Joint Clinical Trials Office

CT Open to Enrollment

A Seamless Phase 2A-Phase 2B Randomized Double-Blind Placebo- Controlled Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients with Early Alzheimer’s Disease (BENFO-TEAM)

The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine, to determine whether it delays or slows the progression of the symptoms of early Alzheimer’s disease. The BenfoTeam clinical trial will test if boosting the amount of thiamine that gets to the brain can slow cognitive decline in people with MCI and mild AD by improving thiamine’s actions in the brain.
   

Alzheimer's Network for Treatment and Diagnostics (ALZ-NET)

The Alzheimer’s Network (ALZ-NET) is a network of clinicians that will collect information about participants’ treatment and care. The purpose of this study is to enable ALZ-NET to collect long-term data of individuals who are evaluated for or receive treatment with a novel FDA-Approved therapy for Alzheimer's Disease (AD). A novel FDA approved therapy approved therapy for AD is a medication that has been approved by the FDA since 2011 and has Alzheimer's disease listed as an indication with the prescribing instructions.
   

Genetic Developmental and Epileptic Encephalopathy Natural History Study for Clinical Trial Readiness

This is a non-interventional longitudinal study of children and adults with Developmental and Epileptic Encephalopathy (DEE) due to a genetic cause. There are six arms of the study.

Arms 1, 2, and 3 are devoted to one example DEE, MEF2C Haploinsufficiency Syndrome (MCHS). Arms 4, 5, and 6 are open to all DEE.

Arm 1 (in-person) will enroll children 0 to 15, who will make in-person visits to Weill Cornell Medicine four times over two years.

A Randomized, Phase III Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First-line Treatment of HER2-positive Gastric Cancer

This clinical trial is designed for men and women with HER2 positive gastric cancer.
   

A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of BHV-1510 (Previously PBI-410) as Monotherapy and in Combination with Anti-Cancer Agents in Participants with Advanced Solid Tumors

This study is being done to evaluate the safety and potential effectiveness of BHV-1510 alone and BHV-1510 in combination with cemiplimab in participants with certain solid tumor cancers. This study will be conducted in 2 parts called “phases.”

A Prospective Multi-Center, Single-Arm Study of Endoscopic Ultrasound-Guided Gastroenterostomy with Lumen-Apposing Metal Stent for Gastric Outlet Obstruction from Malignant Unresectable Disease

This study is for female and male patients who are 18 years of age and older and have Gastric Outlet Obstruction (GOO). GOO is the inability of the stomach to empty its contents into the duodenum.

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection (ECLIPSE 1)

The primary objective of the study is to evaluate the safety of tobevibart+elebsiran in participants with chronic hepatitis Delta virus (HDV) infection. 

Checking In: The Role of Sleep in Cardiovascular Health Among Men Living with HIV

The purpose of this study is to learn more about the daily experiences, including thoughts, feelings, social interactions, medication adherence, and overall health and well-being of gay or bisexual men living with HIV ages 45-64.

There are three study visits:

  1. Day 1/screening visit
  2. 6 month visit
  3. 12 month visit.

Participation will last about 12 months. After the Day 1 study visit, participants are asked to complete a daily diary survey and wear a watch that measures sleep and activity for 30 days.  

A Phase 3b, open label, randomized, standard-of-care control arm, multicenter, superiority study evaluating the efficacy, safety and tolerability of injectable CAB LA + RPV LA in viremic participants living with HIV-1 (CROWN)

The purpose of this study is to evaluate a potential long-acting injectable HIV treatment option for people whose HIV is not undetectable.

The study drug is a long-acting HIV treatment. It is given by injection every other month after 2 started doses. This is in contrast to oral ART, which is designed to be taken daily.

A Phase 2 Crossover Study Of On-Demand Prep Formulations Comparing Rectal And Oral Tenofovir-Based Prep Evaluating Extended Safety, Acceptability, And Pharmacokinetics/Pharmacodynamics

This study is comparing rectal and oral Tenofavir-based prep. The rectal study product is a rectal douche, or enema, that contains the anti-HIV drug tenofovir (TFV). The other study product is taken by mouth and is a combination of two drugs, called emtricitabine (FTC or F) and tenofovir disoproxil fumarate (TDF).

Tenofovir (TFV) rectal douche is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA). Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) is FDA-approved and used according to FDA labeling.