This trial is evaluating whether Donanemab will improve 1 primary outcome and 12 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Baseline through Week 16.
This trial requires 3300 total participants across 2 different treatment groups
This trial involves 2 different treatments. Donanemab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
"At this date no cure of Alzheimer's disease has been established. However, with well-designed prospective trials, it promises to be possible to identify such therapies in the near future." - Anonymous Online Contributor
"Very old age, history of stroke, and use of certain drugs may increase risk and are associated with AD. There is also evidence suggestive of an inverse relationship between AD and cholesterol and blood pressure. The link between smoking and AD remains unclear. More studies over a longer period of time are needed." - Anonymous Online Contributor
"Most patients receive prescription medication for cognition or to manage other symptoms. Of patients with dementia, dementia with Alzheimer disease is generally treated using cholinesterase inhibitors. Other forms of dementia may be treated by anti-depressants, benzodiazepines, or antipsychotics. The use of ginkgo for memory problems and to prevent falls and fractures is also common. Exercise therapy is often used to improve mobility for those with impaired mobility. This list may be expanded and modified as better clinical data become available. The general goals are to help the patient maintain as adequate physical health and quality of life as possible and to prevent deterioration in function." - Anonymous Online Contributor
"The signs of AD are not always easy. While alzheimer's disease is caused by senile plaques and neurofibrillary tangles, it can be asymptomatic or even resemble normal aging. A large amount of time is required to diagnose. Therefore, the symptoms of dementia are what is most important and not the timing of the diagnosis. What are the signs of alzheimer disease? The symptoms of Alzheimer's Disease include changes in cognition, memory, language and motor skill. In order to diagnose, doctors must get an MMSE, a mini-mental state examination, and then a comprehensive neuropsychological test." - Anonymous Online Contributor
"This disease is marked by brain degeneration in two parts: the first has to do with beta-amyloid plaques and tangles in hippocampal CA1 region, and the second part is characterized by the accumulation of tau tangles and tau hyperphosphorylation (this is the first sign of its onset). The second part appears in patients ages 60 years and above. It is marked by loss of memory and deterioration of mental control, language and behavioural coordination." - Anonymous Online Contributor
"About 40,000 new cases of Alzheimer disease will be diagnosed yearly in the U.S. In 2002 only 37% of those diagnosed would have lived to the age of 95." - Anonymous Online Contributor
"The data provide support for the idea that PD and ADC share a common etiology related, at least in part to neurofibrillary tangles. PD-ADC does not appear to be a clinical entity." - Anonymous Online Contributor
"It was found by [CALM] that: (1) Alzheimer disease is a neurodegenerative disease marked by a long incubation period, (2) the likelihood of developing Alzheimer disease increases with longer periods of high cholesterol and low HDL levels, and (3) more research on biomarkers is needed to better understand and treat Alzheimer disease. As of now, there is no cure. Instead, treatment of a dementia patient focuses on managing symptoms, including Alzheimer disease. The [CALM](http://www.calogirl.com/research & therapies) investigates which biomarkers, treatments, or drugs are effective, and which patient populations would benefit most greatly from treatment." - Anonymous Online Contributor
"Our exploratory study suggests that DNT may induce an immunomodulatory profile in human PBMCs independent of complement activation and possibly by interfering with the generation, or uptake of immune complexes by APCs." - Anonymous Online Contributor
"[Though donanemab showed efficacy in a randomized controlled trial, there was no difference between donatemab-treated patients and the placebo-treated control group on the primary outcome after 2 years of follow-up.] We find it difficult to extrapolate the effect of donatemab to a larger population of AD patients, who will more likely be treated with other drugs during the development phase of donatemab." - Anonymous Online Contributor
"Although our study sample size was modest, the improvement in QoL was apparent even at very low dosages (0.25-1.0 mg/kg). Considering that QoL is one of the top aspects for people with AD, this suggests that this antibody could result in some positive impact on people with this disease. Further clinical research in larger samples is required to obtain more precise results at later stages of the treatment. However, given the high rate of loss to follow-up, larger trials with longer follow-up are also needed to confirm the results." - Anonymous Online Contributor
"The efficacy and safety profile of anti-tau monoclonal antibody therapies for Alzheimer's disease are still in preliminary stages of clinical development. This is an ongoing discussion among experts in Alzheimer's disease treatment research. Donanemab and Bapineuzumab, both anti-tau antibodies, are expected to be first-line agents in the treatment of moderate/severe Alzheimer's disease." - Anonymous Online Contributor