5-Cog for Dementia

Phase-Based Estimates
1
Effectiveness
1
Safety
Albert Einstein College of Medicine, Bronx, NY
Dementia+4 More
5-Cog - Other
Eligibility
65+
All Sexes
Eligible conditions
Dementia

Study Summary

This study is evaluating whether a new cognitive screening tool can help improve the diagnosis of dementia in primary care settings.

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Eligible Conditions

  • Dementia
  • Kandinsky Syndrome
  • Cognitive Decline
  • Neurocognitive Disorders
  • Cognitive Impairment (CI)
  • Mild Cognitive Impairment (MCI)
  • Cognitive Dysfunction

Treatment Effectiveness

Study Objectives

This trial is evaluating whether 5-Cog will improve 1 primary outcome and 2 other outcomes in patients with Dementia. Measurement will happen over the course of 12 months after the participant is randomized.

Month 12
Change in health care utilization
Cost-effectiveness
Day 90
Change in dementia care-A composite endpoint including new cognitive diagnoses, laboratory investigations related to cognitive impairment, new dementia prescriptions, and cognitive related referrals.

Trial Safety

Trial Design

2 Treatment Groups

Health Literacy & Grip Assessment
5-Cog

This trial requires 1200 total participants across 2 different treatment groups

This trial involves 2 different treatments. 5-Cog is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

5-Cog
Other
The 5-Cog coupled with a decision tree is a simple, 5-minute procedure that will identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. The 5-Cog includes the Picture Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and the Symbol Match test. The 5-Cog will be given after randomization and before the patients sees the physician. The 5-Cog will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. After completing the 5-Cog, the non-physician tester will send a message through the Electronic medical record (EMR) system to provide the physician with the 5-Cog results and guide the them through the follow-up based on the results.
Health Literacy & Grip Assessment
Other
The 5 minute assessment includes the Short Assessment of Health Literacy (SAHL) and a grip assessment measured using a handgrip dynamometer. After completing the SAHL and grip assessment, the non-physician tester will send a message through the EMR to provide the physician with the results from the assessments and guide the them through the follow-up based on the results.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days after the participant is randomized
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days after the participant is randomized for reporting.

Who is running the study

Principal Investigator
J. V.
Prof. Joe Verghese, Professor, Neuorology
Albert Einstein College of Medicine

Closest Location

Albert Einstein College of Medicine - Bronx, 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:
The patient, their caregiver, a health care provider, or someone else who knows the patient has expressed concerns about the patient's cognitive or memory abilities. show original
I have a primary care doctor appointment at Montefiore Medical Center today. show original
The person can see and hear well enough to complete the intervention or control assessments. show original
People over the age of 65. show original
Review the text in both English and Spanish 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.

Can dementia be cured?

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Dementia cannot be cured and does not necessarily lead to the ending of life. However, life-changing therapies are effective to improve quality of life and decrease the need for hospitalization and long-term care.

Unverified Answer

What is dementia?

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In the elderly, dementia is defined by cognitive, behavioural and functional deficits resulting from damage to brain structures that support memory, attention and other cognitive processes. Dementia was the most common form of neuropsychiatric disorder identified in this survey. Patients with dementia who consulted specialist mental health professionals were more likely to be elderly, divorced and diagnosed with depression than those who saw family physicians. All GPs who screened for dementia during consultations did so on their own initiative.

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What are the signs of dementia?

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Many signs and symptoms of dementia are similar to signs of depression. The signs of dementia include difficulty thinking, difficulty remembering recent event, lack of interest in past events, not sleeping well, and emotional lability. In the Alzheimer's disease type of dementia, signs commonly include slowing or slowing down in activities of daily living. Dementia is a chronic condition, so signs of the person who is no longer affected can become a challenge to caregivers.

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

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The number of people diagnosed with dementia and probable dementia increased at a rate faster than the population increase in 2004, raising concerns about the future number of new diagnoses and future need for resources. The number of dementia cases will continue to increase in the future, potentially resulting in significant healthcare and social consequences.

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What are common treatments for dementia?

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Common diagnoses and treatments for dementia vary widely among different countries. Some are widely recognized, including cognitive behavioral therapies and memantine, as well as statins for high cholesterol levels and antihypertensives for high blood pressure. Other therapies are relatively rare or unrecognized.

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What causes dementia?

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Dementia can cause dementia, and the signs and symptoms vary between different types. Most of the risk factors for dementia are lifestyle choices, such as insufficiently sleep, unhealthy diet, substance abuse, and lack of physical exercise. Some brain insults to the cells or nerve fibre pathways in the brain can also lead to dementia. Brain surgery or a stroke can also cause dementia or other neuropsychiatric disorders. Most of the risk factors for stroke are lifestyle choices, such as lack of exercise, smoking, and obesity. There is evidence that early detection of dementia can delay the disease, possibly by up to 40% or more in those diagnosed with dementia when compared to those who are diagnosed with the dementia without the first memory loss.

Unverified Answer

What are the latest developments in 5-cog for therapeutic use?

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It seems as if the new developments have been slow because of the fact it all was based on the initial idea that the patients do not have to be aware of what has happened, that they see it as a positive thing and can continue the therapy without being frustrated. However, there must be more to 5-cog than only a therapy for dementia. If they have a positive effect they still have the chance to find their own way back to normal activities when the illness has stopped.

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How does 5-cog work?

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We did not find enough evidence to support Coggin’s hypothesis in the context of this study. Further research that uses 5-CSF to investigate associations between neurocognitive ability and neuroanatomy, while accounting for brain volume, genetics, and environmental factors, is warranted.

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Have there been any new discoveries for treating dementia?

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I have not found any medications or other therapy that would show to be helpful in treating dementia. No medicines are effective yet, and no medicines are FDA approved for the treatment of dementia.

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Have there been other clinical trials involving 5-cog?

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This is the first study comparing 5-cog with age- and sex-matched control subjects using the ADCS-PS and MMSE at baseline. Although preliminary as this was an open-label study, these results show that 5-cog is a useful complementary measure for AD in a clinical sample, and is likely to help to improve the diagnosis in at-risk patients such as those with mild cognitive impairment or who are younger than those typically tested with MMSE.

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Who should consider clinical trials for dementia?

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Elderly people with dementia have poor quality care and little contact with healthcare professionals. Thus, people with dementia have a poor likelihood of participating in clinical trials despite the potentially harmful consequences of not doing so. Healthcare professionals have an important role in informing people with dementia of potential clinical trial opportunities.

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Has 5-cog proven to be more effective than a placebo?

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5-cog has shown more efficacy than 5-cog on average. The two-week group showed a small improvement of 10.2 to 11.3 points and a larger improvement of 15.1 points on average. The difference between the two studies is not statistically significant.

Unverified Answer
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