Dementia Clinical Trial
Official title:
Retrospective Analysis of the Comparative Effectiveness of MCI and Dementia Treatment Protocols in a Community-based Specialty Dementia Practice
This retrospective study is a more extensive, confirmatory analysis of the cognitive and
functional outcomes initially seen in 2 groups of MCI/dementia patients in Springfield, MA
and compares specialized dementia care and a comprehensive treatment approach versus usual
care delivered in a non-specialist setting.
The first group of patients (n= 328) was seen by a dementia specialist, who utilized a
standardized assessment and treatment protocol (CNS). This included comprehensive
identification and treatment of hypoxia, sleep-disorders, and other cognitively-impairing
metabolic conditions as well as maximally- dosed FDA-approved medications for dementia,
depression, and PBA.
The second group of patients (n= 280) was seen by non-dementia specialists in the community
and received usual care which did not include comprehensive assessment or treatment of
underlying metabolic derangements or maximal utilization of currently available medications.
This study, evaluating date from a larger cohort (n>800) of specialist-treated
cognitively-impaired patients, will further examine the hypothesis that a comprehensive
dementia treatment protocol yields cognitive stabilization and/or improvement using already
available dementia drugs when compared with usual community care.
From 2008-2013 more than 5,000 patients have been seen by a community-based
internist/psychiatrist specializing in treating cognitively impaired adults suffering from
MCI or dementia due to Alzheimer's Disease, vascular dementia, combined DAT/VAD, FTD, PD,
LBD, as well as dementia due to traumatic brain injury (TBI), alcoholism and autoimmune
diseases.
Cohort 1 includes patients from this specialist practice who were extensively evaluated with
a standardized protocol assessment aimed at identifying all reversible and treatable
conditions adversely affecting cognition, and achieving maximum diagnostic accuracy with
respect to the underlying dementia pathology. The protocol included physical and mental
status examinations, neuroimaging (PET scans and/or MRI's with volumetrics), lab tests,
overnight pulse oximetry, in-lab and ambulatory polysomnography, and gold standard
neuropsychological testing as well as rapid, in-office cognitive testing. The comprehensive
treatment protocol attempted correction of all modifiable and metabolic derangements, and
utilized maximally tolerated FDA approved medications and devices.
Cohort 2 includes patients who were referred by their primary care clinicians or other
non-dementia specialists to a neuropsychology practice for a standardized cognitive
evaluation as part of usual care, but were not treated by a dementia specialist.
This in-depth retrospective analysis is the first attempt to evaluate the comparative
effectiveness of dementia drugs and other treatment interventions in a cognitively impaired
patient group whose baseline metabolic abnormalities were identified, treated and maintained
optimally throughout the course of care versus a patient group not so intensively assessed
or managed.
Outcome measures include objective cognitive testing and functional and behavioral
assessments correlated with prescribed standard dementia medications, reductions in
benzodiazepine, narcotic and antipsychotic use, as well as with baseline and interval
measures of oxygenation adequacy, BNP, CRP, IGF-1, homocysteine, methylmalonic acid, iron
status, Vitamin D 25-OH, and utilization of oxygen and positive airway pressure treatment.
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Observational Model: Cohort, Time Perspective: Retrospective
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