This trial is evaluating whether Simufilam will improve 2 primary outcomes and 10 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Baseline (Study Day 1) to Week 76.
This trial requires 1083 total participants across 3 different treatment groups
This trial involves 3 different treatments. Simufilam is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
"Approximately 200,000 people in the United States aged 65 years and over have the disease diagnosed. If the age and gender trends seen in statistics for prostate cancer are replicated, it is likely that the incidence and incidence of Alzheimer disease will increase over time." - Anonymous Online Contributor
"Symptoms of cognitive impairments occur early in AD, and include memory impairment and executive function deficits. While most clinicians do not diagnose AD, they recognize these symptoms as an indicator of AD, because they are associated with subsequent cognitive deterioration, a hallmark feature of AD. Cognitive complaints are a commonly cited reason for a physician to order a CT scan or to refer a patient to a psychologist for a testing battery. Patient report of cognitive dysfunction or a history of dementia may be another indication for a CT scan." - Anonymous Online Contributor
"Results from a recent paper of this investigation demonstrate that a large-scale clinical AD trial may not produce a statistically significant decrease in disease at 6 and 12 months. It is not currently possible to confidently declare that AD has no treatment effect on disease progression because, as with any placebo-controlled trial, the null hypothesis may not be rejected." - Anonymous Online Contributor
"There appears to be no specific risk factor for development of Alzheimer disease. It is suggested that it may be due to age-related decline in brain functions in the elderly. The age of onset for Alzheimer disease shows large variation between individuals and between regions in the brain. However, it appears that the underlying causes of the diseases may be related to genetic factors.\n" - Anonymous Online Contributor
"The first-line treatments for AD are cholinesterase inhibitors (memantine), which improves cognitive and behavioural deficits and reduces neurocognitive decline. Other treatments include riluzole (another cholinesterase inhibitor used in the United States), and other AChE inhibitors (rocuronium). Anti-epileptic lamotrigine is a mood stabilizer used to treat mood instability; as of 2016, only some of its licensed adult uses remain (for bipolar depression)." - Anonymous Online Contributor
"There are many different presentations of Alzheimer disease (AD). It is the sixth leading cause of death in Canada. It is characterized by progressive memory loss and declines in other cognitive mental processes—particularly speed and mental flexibility—as well as in the ability to learn new tasks. Although the symptoms of AD vary from person to person, they share certain features. They can also vary, in the same person, from mild to severe. Over time, untreated AD can result in significant burden on the quality of life; increased dependence on others, financial hardship, and a need for institutionalization. Patients with Alzheimer disease (AD) have problems with self-care and in many cases have trouble paying bills or other financial obligations." - Anonymous Online Contributor
"Despite some misconceptions, people with Alzheimer disease often are still able to care for themselves for a considerable duration and to receive assistance for activities of daily living. Most patients remain at home with caregivers, although only a minority continue to live in their own homes. Although institutionalization has become a hallmark of the illness's disease course, institutionalized patients have less disability, and a greater likelihood than non-institutionalized patients of continuing at home. In many cases, institutionalization may have been an implicit decision that reflects the patient's family's evaluation of the illness. The authors contend that the patient should have the right to make an explicit choice in the institutionalization decision." - Anonymous Online Contributor
"There is a need for new therapeutic options not only for the treatment of Alzheimer and related disorders but also for prevention. Simufilam looks promising as a therapeutic option in this respect." - Anonymous Online Contributor
"Currently, [simufilam's] mode of action and mechanism of action have not been defined. We provide a rationale and explanations for the effectiveness and mode of action of simufilam, which may assist in designing further clinical studies." - Anonymous Online Contributor
"There is a lack of information about Simufilam, that makes the evaluation and reporting of simufilam a critical issue. The present work shows some limitations to the use of Simufilam as a pharmaceutical product in Turkey." - Anonymous Online Contributor
"It is difficult and inaccurate to pinpoint how often it is seen in a clinical setting, but we conclude that this age range for AD is between 85-90 years old. It is also difficult to determine exact incidence rates for individual diseases, such as dementia, so we have chosen not to list exact data, with the ultimate goal of helping to build an accurate understanding of the disease spectrum so that future research and treatment strategies may be improved. This information, while limited, can aid in clinical diagnosis and provide clinicians with data which might help to identify and manage the disease." - Anonymous Online Contributor
"Although family history of dementia does not influence whether someone with a clinical risk score is suitable for participation in a clinical trial, participants with a recent history of dementia are more likely to withdraw from clinical trials." - Anonymous Online Contributor