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Study Summary
This trial is studying the safety and effectiveness of a new drug called NE3107 compared to a placebo in 316 adults with mild to moderate Alzheimer's disease. The trial will last for 30 weeks and will measure the change in the patients' condition using two different tests. There is also a subset of patients who will have MRI and PET scans as part of the trial.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your score on the Geriatric Depression Scale Short Form (GDS SF) is higher than 8 during the screening. However, if you have mild depression or if your depression is related to Alzheimer's disease, you will not be excluded. You can still participate if you have been taking anti-epileptic medication or antidepressants, as long as the dose has been the same for at least 60 days before the screening.You have had breast cancer in the past.You have a history of violent or aggressive behavior that could disrupt your involvement in the study.If you are currently taking certain medications for memory and cognitive function (like donepezil, galantamine, rivastigmine, or memantine) before the study starts, you may not be eligible to participate.You have had a problem with alcohol or drugs within the past 2 years, according to a specific guide used by doctors to diagnose mental health conditions.You have a modified Hachinski Ischemic Scale score of ≤4 at Screening (V1).You have had recent thoughts of hurting yourself or have attempted suicide in the past.You have a history of memory problems or have been diagnosed with dementia by a healthcare professional.You have mild to moderate Alzheimer's disease, as determined by specific criteria.You have a history of epilepsy or ongoing seizures that require treatment, or you have had a seizure or passed out in the past year.
- Group 1: NE3107
- Group 2: placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still opportunities for patients to enroll in this research?
"The details available on clinicaltrials.gov show that this trial is looking for participants. This study was first advertised on August 5th, 2021 and the listing was last updated September 26th, 2022."
What is the NE3107 drug's official status with the FDA?
"NE3107's Phase 3 status means that, while there is data supporting its efficacy, there is also robust safety data from multiple rounds of testing. Our team rates it a 3 on our safety scale."
How many people are being given the chance to participate in this experiment?
"This trial requires 316 participants that fit the bill in terms of specified inclusion criteria. Those interested can go to South Florida Research Phase I-IV in Miami Springs, Florida or Charter Research in Lady Lake, Arizona (among other places)."
Are there specific qualifications that participants must meet in order to join this research project?
"The patients that this study aims to enroll must suffer from alzheimer disease, and be within the age bracket of 60 to 85 years old. In total, 316 individuals are needed for this clinical trial."
Would this test be appropriate for elderly patients?
"The aim of this clinical trial is to test the medication on patients who are within the age range of 60 to 85 years old."
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What portion of applicants met pre-screening criteria?
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