Solanezumab for Overinclusion

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Columbia University Medical Center, New York, NY
Overinclusion
Solanezumab - Drug
Eligibility
65+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can slow the progression of memory problems associated with brain amyloid.

See full description

Treatment Effectiveness

Effectiveness Estimate

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

Study Objectives

This trial is evaluating whether Solanezumab will improve 1 primary outcome and 8 secondary outcomes in patients with Overinclusion. Measurement will happen over the course of Baseline, Week 240.

Baseline, Week 240
Change from Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers
Change from Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr)
Change from Baseline of CSF Concentrations of Amyloid Beta (Abeta)
Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI)
Week 336
Change from Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score
Change from Baseline in Cognitive Function Index (CFI)
Change from Baseline of the Preclinical Alzheimer Cognitive Composite (PACC)
Baseline, Week 336
Change from Baseline on the Clinical Dementia Rating-Sum of Boxes score (CDR-SB)
Change from Baseline on the Computerized Cognitive Composite (C3)

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Solanezumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 1150 total participants across 2 different treatment groups

This trial involves 2 different treatments. Solanezumab 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.

Solanezumab
Drug
Solanezumab (400-1600 milligrams) intravenously (IV) every 4 weeks for 240 weeks. Participants who enter the open-label extension will receive solanezumab IV.
PlaceboPlacebo IV every 4 weeks for 240 weeks. Participants who enter the open-label extension will receive solanezumab IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Solanezumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 240; baseline, week 336
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, week 240; baseline, week 336 for reporting.

Closest Location

Columbia University Medical Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30
Has a global Clinical Dementia Rating (CDR) scale score at screening of 0
Has a Logical Memory II score at screening of 6 to 18
Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain amyloid pathology at screening
Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)

Patient Q&A Section

What is the latest research for overinclusion?

"There exists a need for new studies to test the evidence for overinclusion in the medical literature, as it is clear that many studies that fail to find an effect have methodological flaws that impede their interpretation." - Anonymous Online Contributor

Unverified Answer

How many people get overinclusion a year in the United States?

"About 1 million people in the United States experience overinclusion at least once a year. More than 40% of these patients continue experiencing the disorder at least a few times a year for more than 12 months. Some people never get overinclusion-induced tic disorders. The incidence of these disorders increases with age." - Anonymous Online Contributor

Unverified Answer

What are the signs of overinclusion?

"When a clinical picture including abnormal beliefs and symptoms is seen in a patient, a detailed history should be taken to gain an accurate history of the person's thoughts and behaviours that may help with their diagnosis. The signs of excessive beliefs about non-existent illnesses, or "overinclusion" should be noted and investigated further." - Anonymous Online Contributor

Unverified Answer

What are common treatments for overinclusion?

"Most patients with this condition were managed with nonoperative measures. Lateral retraction was the most effective strategy, and patients achieved favorable results with nonsurgical intervention only, especially with less aggressive procedures. The less invasive and non operative options for this condition should be further evaluated." - Anonymous Online Contributor

Unverified Answer

Can overinclusion be cured?

"Although the majority of women who want a second child are well-informed and self-determine their own ovulation, infertility and contraception treatments, in our study, about two thirds did not consult their [doctor or midwife] about the possibility or benefits of contraception and almost one quarter (17) did not use a contraceptive method as stated." - Anonymous Online Contributor

Unverified Answer

What is overinclusion?

"Within the bounds of this study, it will help patients understand the various options available to them for treatment and the risk of treatment failure." - Anonymous Online Contributor

Unverified Answer

What causes overinclusion?

"Results from a recent paper indicate that PFCs overinclusion is associated with specific developmental and behavioral abnormalities, including an increased likelihood of social problem behaviors." - Anonymous Online Contributor

Unverified Answer

What is solanezumab?

"[As a result of multiple questions about solanezumab in clinical trials, we can only speculate for sure that it may help a small number of patients with high-grade, advanced choroidal neovascularization and macular oedema when treatment with an anti-VEGF regimen fails or has side effects that make it no longer an option] (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324983/overview/). However, patients may be eligible based on baseline data and signs and symptoms." - Anonymous Online Contributor

Unverified Answer

How serious can overinclusion be?

"- I. Vascular disease\n- II. Other causes of stroke\n- III. Myocardial infarction\n- IV. Deep venous thrombosis\n- V. Pericarditis\n- VI. Other vascular disease\n- VII. Infective or parasitic diseases\n- VIII. Other vascular disease\n- IX. Congenital heart disease\nThe overall results of the trial were very good considering its small sample size." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving solanezumab?

"Solanezumab is currently approved in the United States only for the treatment of moderate-to-severe plaque psoriasis. The drug's label does not contain any contraindications for patients with Crohn's disease, a known risk factor for death, as is also true for patients with a previous recurrence of Crohn's disease (i.e., Crohn's relapse). It is very conceivable that other indications may be discovered with further followup of this drug in patients with Crohn's disease, and thus more patients might be eligible for enrollment in future trials." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for overinclusion?

"Although enrollment in clinical studies for overinclusion is a growing issue in the research community, a comprehensive assessment of all clinical trial data must evaluate the scientific merit of all potential participants. The most accurate assessment can be made by assessing whether potential research participants can be accurately ascertained for enrollment by applying the inclusion and exclusion criteria that are specified for a study." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of overinclusion?

"Overinclusion is an objective measure of uncertainty regarding the clinical significance of a test result. It may serve as a useful decision aid in making decisions concerning whether to repeat a specific test using the modified SIR criteria for further clinical analysis." - 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.
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