What side effects are associated with this type of intervention?

Common treatments for cognitive impairment, particularly in dementia, include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine. These medications can cause side effects such as nausea, vomiting, diarrhea, muscle cramps, fatigue, insomnia, and, less commonly, bradycardia and syncope. Cognitive behavioral therapy (CBT) is also used to manage symptoms and improve quality of life, with minimal side effects primarily related to the psychological nature of the therapy.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cognitive impairment, particularly in the context of dementia. Cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine are commonly used to manage symptoms of Alzheimer's disease and other dementias. Memantine, an NMDA receptor antagonist, is another approved treatment that is often used in combination with cholinesterase inhibitors for moderate to severe Alzheimer's disease. These treatments aim to improve cognitive function and slow the progression of symptoms. The 5-Cog brief cognitive assessment tool, while not a drug, represents an innovative approach to improving the detection and management of cognitive impairment by addressing technical, cultural, and logistical barriers in diverse populations.

What other types of research exist?

Promising alternatives to the 5-Cog brief cognitive assessment include the Alabama Brief Cognitive Screener (ABCs) and the electronic version of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (eADAS-Cog). The ABCs is designed for quick cognitive screening and has been validated in memory disorder clinics. The eADAS-Cog offers greater standardization and reduced rater error, making it a reliable tool for cognitive assessment.

← Back to Search

5-Cog Assessment for Dementia

Q: What is the mechanism of action of this treatment?

Common treatments for cognitive impairment include cholinesterase inhibitors and memantine. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, increase acetylcholine levels in the brain by inhibiting its breakdown, thereby enhancing communication between nerve cells involved in memory and learning. Memantine regulates glutamate activity, preventing excessive stimulation that can lead to neuronal damage. These treatments are vital for managing symptoms and improving the quality of life for cognitive impairment patients. The 5-Cog brief cognitive assessment tool is designed to facilitate early detection of cognitive impairment, enabling timely intervention with these treatments.

N/A

Recruiting

Led By Erica Weiss, PhD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a quick and easy memory test called 5-Cog in older adults, especially those from underserved communities. The test helps doctors find memory problems early, leading to faster treatment and better care.

Who is the study for?

This trial is for individuals aged 65 or older who have concerns about their memory or thinking but haven't been diagnosed with dementia. It's not open to those already diagnosed with dementia or living permanently in nursing facilities.

What is being tested?

The study compares a new brief cognitive assessment called the 5-Cog Paradigm, which is quick and culturally sensitive, against enhanced usual care to see if it better detects new cases of mild cognitive impairment and dementia in primary care settings.

What are the potential side effects?

Since this trial involves a non-invasive cognitive assessment tool rather than medication, there are no direct physical side effects expected from participating in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

New cognitive impairment diagnoses in the 90-day period following presentation of cognitive concern to the primary care physician (PCP).

Secondary study objectives

Improved dementia care in the 90-day period following presentation of cognitive concern to the primary care provider (PCP).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)Experimental Treatment1 Intervention

A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. If cognitive concerns are endorsed the 5-Cog battery will be conducted. The simple, \<5-minute cognitive assessment will reliably identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. Depending on whether the 5-Cog results are normal or abnormal on any one of the 3 tests, appropriate clinical decision support tools are provided to the primary care physicians in electronic medical record. The primary care physicians are not instructed to follow 5-Cog suggestions verbatim but use their clinical judgment.

Group II: Enhanced usual careActive Control1 Intervention

Educational sessions for primary care physicians and clinic staff regarding cognitive detection and medical billing will be conducted. A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. The results will be provided to primary care physicians.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cognitive impairment include cholinesterase inhibitors and memantine. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, increase acetylcholine levels in the brain by inhibiting its breakdown, thereby enhancing communication between nerve cells involved in memory and learning. Memantine regulates glutamate activity, preventing excessive stimulation that can lead to neuronal damage. These treatments are vital for managing symptoms and improving the quality of life for cognitive impairment patients. The 5-Cog brief cognitive assessment tool is designed to facilitate early detection of cognitive impairment, enabling timely intervention with these treatments.