5-Cog Assessment for Dementia
Recruiting at 1 trial location
JV
EA
EW
Overseen ByErica Weiss, PhD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Albert Einstein College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What makes the 5-Cog Paradigm treatment unique for dementia?
Research Team
Malaz Boustani, MD, MPH
Principal Investigator
Indiana University
JV
Joe Verghese, MD
Principal Investigator
Stony Brook University
EW
Erica Weiss, PhD
Principal Investigator
Albert Einstein College of Medicie
Eligibility Criteria
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.Inclusion Criteria
I am 65 years old or older.
Presence of cognitive concerns
Exclusion Criteria
I live in a nursing home permanently.
Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians)
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants undergo cognitive concern screening and, if concerns are endorsed, the 5-Cog battery is conducted
90 days
Multiple visits (in-person)
Follow-up
Participants are monitored for new cognitive impairment diagnoses and improved dementia care
90 days
Follow-up assessments (in-person or virtual)
Implementation and Cost-effectiveness Analysis
Examine implementation issues and cost-effectiveness of the 5-Cog paradigm
Treatment Details
Interventions
- 5-Cog Paradigm
- Enhanced usual care
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Albert Einstein College of Medicine
Lead Sponsor
Trials
302
Recruited
11,690,000+
Northwestern University
Collaborator
Trials
1,674
Recruited
989,000+
Indiana University
Collaborator
Trials
1,063
Recruited
1,182,000+
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Trials
1,403
Recruited
655,000+
Findings from Research
The Chinese version of the ADAS-Cog, designed with pictures for better accessibility, demonstrated high reliability and consistency, making it a suitable tool for assessing cognitive function in individuals with varying levels of dementia.
This assessment tool effectively detects early signs of dementia through memory items and monitors disease progression using language items, proving its utility in clinical settings for Chinese Alzheimer's patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The Alzheimer's Disease Assessment Scale: findings from a low-education population.Liu, HC., Teng, EL., Chuang, YY., et al.[2019]
The ADAS-Cog is the most commonly used cognitive assessment tool in dementia trials, but it has limitations as it does not evaluate attention, executive function, or agnosia, making it less suitable for non-Alzheimer's dementias.
There is a need for more tailored cognitive assessment tools for different types of dementia, such as frontotemporal dementia, as existing tools like the ADAS-Cog may not adequately capture the cognitive deficits present in these patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Target symptoms and outcome measures: cognition.Kirk, A.[2019]
The ADAS-Cog assessment tool effectively differentiates between healthy individuals, those with Mild Cognitive Impairment (MCI), and Alzheimer's Disease (AD) in a study of 650 participants, showing significant score differences among the groups.
Optimal cut-off points for diagnosing MCI and AD were established, with the ADAS-Cog showing high specificity for AD (98%) but lower sensitivity for MCI (58%), indicating it is more reliable for identifying advanced cognitive decline rather than early impairment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Validation study of the Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) for the Portuguese patients with mild cognitive impairment and Alzheimer's disease.Nogueira, J., Freitas, S., Duro, D., et al.[2019]
References
The Alzheimer's Disease Assessment Scale: findings from a low-education population. [2019]
Target symptoms and outcome measures: cognition. [2019]
Validation study of the Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) for the Portuguese patients with mild cognitive impairment and Alzheimer's disease. [2019]
The Cambridge Cognitive Examination (CAMCOG): validation of the Hebrew version in elderly demented patients. [2004]
Free-Cog: Pragmatic Test Accuracy Study and Comparison with Mini-Addenbrooke's Cognitive Examination. [2020]
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