CY6463 for Alzheimer Disease

Phase-Based Estimates
1
Effectiveness
2
Safety
Clinical Endpoints, Scottsdale, AZ
Alzheimer Disease+1 More
CY6463 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Alzheimer Disease

Study Summary

This study is evaluating whether a drug called CY6463 is safe and tolerable for people with Alzheimer's disease.

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Eligible Conditions

  • Alzheimer Disease
  • Alzheimer's Disease With Vascular Pathology

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CY6463 will improve 1 primary outcome in patients with Alzheimer Disease. Measurement will happen over the course of From first dose of study treatment through ~14 (±4) days after the final dose.

From first dose of study treatment through ~14 (±4) days after the final dose
Incidence of treatment-emergent adverse events (TEAEs) from study drug initiation through Follow-up

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Placebo
CY6463
Placebo group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. CY6463 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.

CY6463
Drug
Placebo
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose of study treatment through ~14 (±4) days after the final dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from first dose of study treatment through ~14 (±4) days after the final dose for reporting.

Closest Location

Clinical Endpoints - Scottsdale, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You agree to refrain from donating sperm from the Screening visit through 90 days after taking the final study drug dose. show original
Provide written informed consent prior to the performance of any protocol-specified procedure or, if unable to provide informed consent due to cognitive status, provides assent to participate, with a legally authorized representative (LAR) providing written informed consent on behalf of the participant.
60 years of age or older
Meets core clinical criteria for probable AD dementia according to the 2011 National Institute on Aging-Alzheimer's Associated guidelines. Can be based on medical history.
You have a mini-mental state examination score of 20 to 26 (inclusive). show original
Confirmation of AD pathophysiology
You have at least 2 risk factors for cardiovascular disease per protocol criteria. show original
Magnetic resonance imaging (MRI) scan (existing MRI obtained ≤6 months before Screening is acceptable) findings of mild-to-moderate subcortical small-vessel disease
You are receiving concomitant or chronic medication(s) show original
If male, agrees to use protocol-specified, effective contraception methods from the signing of the informed consent form (ICF) until ≥90 days after taking the final study drug dose.

Patient Q&A Section

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

Can alzheimer disease be cured?

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The brain can be regenerated to a certain degree, but the brain is not and cannot be regenerated to full functioning status in humans with Alzheimer's.\n

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What are common treatments for alzheimer disease?

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Anti-cholinergic medications like antipsychotic and antihistamine medications and hypnotics like benzodiazepines/barbiturates were all highly prescribed. Use of antiemetics by physicians was also commonplace, but they were rarely prescribed by themselves.

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

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Based on information from the Alzheimer Disease and Associated Disorders Information system (ADARIS), Alzheimer disease currently affects approximately 4 million Americans each year. Most people will get dementia before age 80, but many have at least a few years where their memory and cognitive abilities are unimpaired.

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What causes alzheimer disease?

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The most frequently found causes of AD are genetics; environmental hazards; and some drugs. The causes of AD are not yet fully understood. More work on genetics in AD and in finding causes may help to understand the disease process.

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What are the signs of alzheimer disease?

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Symptoms of AD include the following: dementia with cognitive dysfunction and behavioral problems; visual hallucinations (especially in Alzheimer's disease); paranoia; mood and sleep disorders; memory or cognitive impairments; and difficulty with thinking and communicating.\n

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What is alzheimer disease?

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It is a disease that causes significant brain deterioration and progressive cognitive impairment, and it was found that the incidence of the disease increased as the level of education increased up to 7 years, and it was found that the risk of occurrence increased by 3 in every 2,000 women who did not have the disease and who started life at a younger age.

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Is cy6463 safe for people?

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Recent findings provides the first reported clinical pharmacokinetics of cy6463 after oral administration in a community setting. The mean area under the concentration-time curve was similar to that from studies in healthy volunteers. Cy6463 is well tolerated in people with moderate to severe cognitive impairment; however, further studies are needed that assess the safety and efficacy of this new compound, especially in people with dementia.

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Have there been any new discoveries for treating alzheimer disease?

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Recent studies show that brain stimulation may have beneficial effects for Alzheimer's patients. In addition, evidence shows that low-level laser therapy is useful for alleviating several symptoms for dementia patients.

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Have there been other clinical trials involving cy6463?

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There have not been any other clinical trials investigating the effect of cy6463 which have been published in peer-reviewed journals since 2013. However, [UCLA study, above] has shown a number of favorable outcomes when comparing cy6463 with placebo. In addition, there are no known side effects or side effects in relation to the drug which could lead to a drug interaction. Thus, cy6463 is likely safe to use and has the probability to be a highly effective treatment option in patients with Alzheimer's disease.

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What is the latest research for alzheimer disease?

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Patients are seeking help for memory problems, often from a neurologist. Patients are also looking for interventions to ease their memory and emotional difficulties. However, while more research continues, the evidence base for treating and preventing Alzheimer disease may continue to be sparse and uncertain.

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Has cy6463 proven to be more effective than a placebo?

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This small case series did not confirm previous claims, that cy-6464 appears to be more effective than a placebo for moderate-severe Alzheimer's disease. However, patients can benefit from therapy, or be harmed, through unwanted side effects. Cy-6464 treatment should only be used under the supervision of a professional.

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What is the average age someone gets alzheimer disease?

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There are many factors and individual histories that determine when a person will develop Alzheimer disease, including age at onset. Since it is believed that the genes involved in Alzheimer disease change over the life of an individual, one cannot pinpoint exactly the age at which Alzheimer will begin to develop. The most common time to get Alzheimer's is in your 70s. It is imperative for people to be proactive in their health and start [doing things like eating a healthy diet], working on their brain, [doing things like exercising regularly] and getting screened for early Alzheimer's by your doctor. While the outlook for those who are diagnosed with Alzheimer's is [always poor, because it is a disease with a 100% mortality rate (i.e.

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