Simufilam for Alzheimer Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
St. Joseph's Health Care London, London, Canada
Alzheimer Disease
Simufilam - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether simufilam is safe and effective in people with Alzheimer's disease.

See full description

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

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.

Week 76
Change from baseline in plasma biomarker SavaDx
Change from baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
Change from baseline in the MMSE
Change from baseline in the Neuropsychiatric Inventory (NPI)
Change from baseline in the Zarit Burden Interview (ZBI)
Change from baseline in the integrated Alzheimer's Disease Rating Scale (iADRS)
Changes from baseline in CSF neurogranin, neurofilament light chain, total tau, phospho-tau181 (P-tau181), soluble triggering receptor expressed on myeloid cells 2 (sTREM2), and Aβ42
Changes from baseline in amyloid and tau PET
Changes from baseline in brain volume via MRI
Changes from baseline in plasma biomarkers P-tau181 and neurofilament light chain

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

3 Treatment Groups

Simufilam 50 mg
1 of 3
Simufilam 100 mg
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

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.

Simufilam 50 mg
Drug
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks
Simufilam 100 mg
Drug
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks
Placebo
Drug
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (study day 1) to week 76
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline (study day 1) to week 76 for reporting.

Closest Location

St. Joseph's Health Care London - London, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person has an MMSE score of between 16 and 27. show original
A Clinical Dementia Rating (CDR) assessment is required for all patients with a diagnosis of dementia show original
People who have taken part in a clinical trial testing a new drug to treat the underlying cause of Alzheimer's disease may be able to take part in this study. show original
The individual meets the criteria for people in clinical Stage 4 or 5 of the Alzheimer's continuum, as set by the National Institute on Aging and the Alzheimer's Association. show original
, and not meeting the study inclusion criteria, was found in 96 of the 377 (25%) individuals screened show original
To be eligible for the study, participants must have been receiving stable background doses of any AD medications for at least 12 weeks prior to randomization. show original
The subject has not smoked cigarettes for at least 3 years. show original
Availability of a study partner
Key

Patient Q&A Section

How many people get alzheimer disease a year in the United States?

"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

Unverified Answer

What are the signs of alzheimer disease?

"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

Unverified Answer

Can alzheimer disease be cured?

"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

Unverified Answer

What causes alzheimer disease?

"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

Unverified Answer

What are common treatments for alzheimer disease?

"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

Unverified Answer

What is alzheimer disease?

"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

Unverified Answer

How serious can alzheimer disease be?

"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

Unverified Answer

What are the latest developments in simufilam for therapeutic use?

"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

Unverified Answer

How does simufilam work?

"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

Unverified Answer

What is simufilam?

"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

Unverified Answer

What is the average age someone gets alzheimer disease?

"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

Unverified Answer

Who should consider clinical trials for alzheimer disease?

"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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Alzheimer Disease by sharing your contact details with the study coordinator.