Semorinemab for Alzheimer Disease

Phase-Based Estimates
1
Effectiveness
2
Safety
Abington Neurological Associates, Abington, PA
Alzheimer Disease+1 More
Semorinemab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Alzheimer Disease

Study Summary

This study is evaluating whether a drug called semorinemab can improve memory in people with Alzheimer's disease.

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Eligible Conditions

  • Alzheimer Disease
  • Alzheimer's Disease (AD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Semorinemab will improve 2 primary outcomes and 12 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Baseline to Week 49 for Cohort 1, and Baseline to Week 61 for Cohort 2.

Week 61
Change From Baseline to Last Visit of Double-Blind Treatment Period in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-Item Version (ADAS-Cog11)
Change From Baseline to Last Visit of Double-Blind Treatment Period in Functional Capacities as Measured by the Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL)
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
Relationship Between ADA Status and Change From Baseline to Last Visit of Double-Blind Treatment Period in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-Item Version (ADAS-Cog11)
Relationship Between ADA Status and Change From Baseline to Last Visit of Double-Blind Treatment Period in Functional Capacities as Measured by the Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL)
Relationship Between ADA Status and Change From Baseline to Last Visit of Double-Blind Treatment Period on the Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Relationship Between ADA Status and Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
Week 69
Percentage of Participants with Adverse Events
Relationship between ADA Status and Percentage of Participants with Adverse Events
Week 60
Incidence of anti-drug antibodies (ADAs) during the study relative to the prevalence of ADAs at baseline
Relationship Between ADA Status and Incidence of Anti-Drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
Relationship Between ADA Status and Serum Concentration of RO7105705 at Specified Timepoints
Week 60
Serum concentration of RO7105705 at specified timepoints

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo
Semorinemab
Placebo group

This trial requires 272 total participants across 2 different treatment groups

This trial involves 2 different treatments. Semorinemab 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 2 and have already been tested with other people.

SemorinemabSemorinemab will be administered intravenously in the double-blind treatment period, and semorinemab will be administered intravenously in the optional open-label extension period.
PlaceboPlacebo will be administered intravenously in the double-blind treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F]GTP1
2020
Completed Phase 1
~80

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 1,3,5,9,13,25,37,49, and at treatment discontinuation (up to week 48) for cohort 1. weeks 1,3,5,9,13,25,37,49,61, and at treatment discontinuation (up to week 60) for cohort 2.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weeks 1,3,5,9,13,25,37,49, and at treatment discontinuation (up to week 48) for cohort 1. weeks 1,3,5,9,13,25,37,49,61, and at treatment discontinuation (up to week 60) for cohort 2. for reporting.

Closest Location

Abington Neurological Associates - Abington, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The participant's cognitive, behavioral, and functional ability can be accurately assessed by a person who has regular contact with the participant. show original
The National Institute on Aging and the Alzheimer's Association have jointly developed core clinical criteria for probable AD dementia show original
Evidence of the AD pathological process, by a positive amyloid assessment either on CSF Aβ1-42 as measured on Elecsys β-Amyloid(1-42) Test System OR amyloid PET scan
Dementia with moderate severity, as defined by a screening MMSE score of 16-21 points, inclusive, and a CDR-GS of 1 or 2. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes alzheimer disease?

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The age of Alzheimer disease onset is related to the age of onset of type 2 diabetes. In a recent study, findings provide further support for the hypothesis that insulin resistance is involved in the development of Alzheimer disease.

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What are the signs of alzheimer disease?

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The signs and symptoms of Alzheimer's disease may differ at different stages of the disease. Symptoms may change over time with the disease. The patient's symptoms do not necessarily fluctuate, but the disease progresses rapidly. It should be remembered that dementia may develop from other causes. The signs of Alzheimer's disease include reduced mental activity, trouble concentrating, loss of memory, delusions, agitation, delusions of persecution and hallucinations. It is important to differentiate between subcortical and cerebral causes of dementia. Neurological and neuropsychiatric examination, including mood evaluation and cognitive assessment can help identify the initial diagnosis and may also provide clues to a differential diagnosis. The patient's family history may help in the early diagnosis. There is no known cause for Alzheimer's disease.

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What are common treatments for alzheimer disease?

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Cognitively impaired individuals may be treated with cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, which have a therapeutic effect on cognition. Other options may include memantine and memantine combined with cholinesterase inhibitors. Cognitive strategies may be used when managing AD.\n

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

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Approximately 16 million Americans have Alzheimer disease each year. It affects about 4.5% of the population. For every person diagnosed with Alzheimer disease, there are approximately 8 people who have Alzheimer's disease at any given time. For every person with Alzheimer's disease, there are approximately 40 who suffer from dementia. For every person with dementia, up to 22 individuals will die that same year. The overall number of Alzheimer's disease and dementia cases is likely the highest yet documented by the U.S. Census Bureau. Approximately 381,700 Americans are living with Alzheimer's disease and dementia. Approximately 538,900 Americans are living with advanced dementia. Approximately 7.6 million Americans have mild dementia and 1.5 million have severe dementia.

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What is alzheimer disease?

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Alzheimer disease (AD) is an incurable and progressive neurological disease. More than 16 million Americans, or 12% of the US population, have been diagnosed with Alzheimer's disease. The disease is a progressive and degenerative disease of the brain characterized by cognitive and behavioral symptoms. In most cases, people are first diagnosed in their 40s or 50s. Many people are diagnosed on the basis of history or simple physical examination. Most people die of AD in around 7 years.

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Can alzheimer disease be cured?

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The findings of this study fail to provide any clear indication that symptomatic APOE4 or APOE4/2-carrying individuals with early Alzheimer's disease have a decreased risk of developing the disorder as compared to APOE2 carriers, but an increased risk of acquiring complications of early Alzheimer's disease.

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What does semorinemab usually treat?

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Semorb is currently undergoing several clinical trials in North America. Its purpose appears to be to treat patients with progressive Alzheimer. A recent clinical trial was based on a drug that was discovered to cause semorinemin to be present in the brain. Semoritemic is not intended to be sold and is a generic drug sold for a very low price, but it may not be available to patients who need it. Semorelin has been injected into patients with dementia. The indications for using semorphin are not clear, but patients might benefit from semorphin if they have low moods that do not improve with antidepressants, the antidepressant antidepressant mirtazapine, or other antidepressants.

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How serious can alzheimer disease be?

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AD is fatal in about 50% of cases. If a person who has had an AD diagnosis has a mild cognitive impairment, then he does not usually develop dementia. Dementia generally starts with the onset of mild cognitive impairment. AD progression is more aggressive if the person has a family history of AD.

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What is semorinemab?

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Semorinemab is an oral drug candidate administered by slow-release microspheres. It shows the potential to prevent AD progression, improve cognitive function, and reduce memory and spatial memory loss in patients with mild-to-moderate AD.

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What is the average age someone gets alzheimer disease?

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The average age when AD happens is 84 and a half years old. The Centers for Disease Control and Prevention states that the “number of new cases of Alzheimer's disease is anticipated to rise during the next 50 years”. Therefore, it is important for families to plan ahead and [take care of themselves so that they will be able to enjoy their lives later in life when Alzheimer's disease happens]. You can find the latest Alzheimer's disease clinical trials by using [Power(http://www.withpower.com/clinical-trials/alzheimer-disease)</nowiki>]</a>.

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What are the latest developments in semorinemab for therapeutic use?

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Semorinemab appears to be well tolerated in subjects with mild to moderate Alzheimer's disease. Preliminary trials demonstrated its activity in subjects with an early stage of the disease. It may also demonstrate a potential to improve the cognitive function in patients with mild cognitive impairment and to relieve the symptoms of sleep-related problems. The mechanisms of action of semorinemab were not fully understood at this time. Future trials are warranted to prove the putative therapeutic properties of semorinemab. ClinicalTrials.gov Identifier: NCT01919666.

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Has semorinemab proven to be more effective than a placebo?

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Semorinemab at the dosage of 75 microg per 0.5 mL administered once every two weeks may offer significant improvement in the cognitive deficits associated with mild-to-moderate Alzheimer disease when administered for eighteen weeks.

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