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COMPARATIVE EFFECTIVENESS OF MCI and DEMENTIA TREATMENTS IN A COMMUNITY-BASED DEMENTIA PRACTICE

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ClinicalTrials.gov Identifier: NCT02860338
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Clionsky Neuro Systems Inc.

Brief Summary:

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.


Condition or disease
Mild Cognitive Impairment Dementia Hypoxia Hyperhomocysteinemia Vitamin B 12 Deficiency Iron Deficiency Anemia TBI Neurodegenerative Disorders Alzheimer's Disease Vascular Dementia Brain Injuries Tauopathies Parkinson's Disease Lewy Body Dementia Frontotemporal Dementia TDP-43 Proteinopathies

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis of the Comparative Effectiveness of MCI and Dementia Treatment Protocols in a Community-based Specialty Dementia Practice
Study Start Date : January 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Group/Cohort
GROUP 1- CNS Protocol

Patients in a specialized dementia practice. Evaluated and treated for hypoxia, elevated BNP, hyperhomocysteinemia, B 12 deficiency as measured by elevated methymalonic acid, Vitamin D 25-OH deficiency, elevated CRP, and decreased IGF-1, and other metabolic abnormalities.

Treated with maximal doses of acetylcholinesterase inhibitors, memantine, methylfolate/methylB12/N-acetylcysteine, dextromethorphan/quinidine, and SSRI's; dose and duration based on protocol.

GROUP 2- Community Care
Patients referred to a neuropsychology practice for cognitive evaluation and treated for MCI or dementia by their primary care clinician or non-dementia specialist according to specific provider's usual practice pattern.



Primary Outcome Measures :
  1. Cognitive testing - Memory Orientation Screening Test (MOST) [ Time Frame: At each office visit, for 96 months, until patient left the practice, or until date of death ]

Secondary Outcome Measures :
  1. Resting and ambulatory pulse oximetry in office [ Time Frame: At each office visit, for 96 months, until patient left the practice, or until date of death ]
    Recording of the pulse oximetry data from a standard Nonan pulse oximeter while the patient is at rest and/or ambulation at office visits made by the patient as determined by usual patient care in a naturalistic setting

  2. Nocturnal pulse oximetry [ Time Frame: Ordered and Initial office visit or subsequent patient visits, for 96 months, until the patient left the practice, or until the date of death. ]
    Recording of SpO2, baseline, nadir, time <=88%, oxygen desaturation index, heart rate range, nadir heart rate, maximum heart rate using standardized, FDA-device approved, commercially available nocturnal pulse oximeters

  3. Polysomnography in-lab and ambulatory ( in patient's residence) [ Time Frame: Initial study ordered at first or subsequent office visit for for 96 months, until the patient left the practice, or until the date of death. ]
    Polysomnography date obtained from standardized, commercially available, FDA approved instruments, including: number of nights studied (1-3), apnea-hypoxia index (AHI), nadir heart rate, heart rate range, nadir SpO2, diagnosis reported

  4. Laboratory values: Chem 20, CBC/diff, BNP, CRP, iron, iron/TIBC, ferritin, homocysteine, methylmalonic acid, Vitamin D 25-OH, RPR/FTA-ABS/TPPA, IGF-1 [ Time Frame: Ordered at initial and subsequent office visits for 96 months, until patient left the practice, or until date of death ]

Other Outcome Measures:
  1. Medications - prescribed [ Time Frame: Ordered ar Initial office visit and any subsequent visits for Ordered at initial and subsequent office visits for 96 months, until patient left the practice, or until date of death ]
    Initiation, duration of use, dosing levels, adverse side effects, discontinuation/reason for discontinuation of prescribed dementia medications or other drugs, including but not limited to donepezil, rivastigmine, galantamine, memantine, methlyfolate/methylB12/N-acetylcysteine, cholecalciferol, dextromethorphan/quinidine, eszopiclone, citalopram, escitalopram, and sertraline

  2. Oxygen - prescribed [ Time Frame: Ordered at either at initial or subsequent office visit for a period of 96 months, or until patient left the practice, or until date of death ]
    Initiation, duration, and reason for discontinuation of O 2 nasal cannula supplementation either 24 x 7, or only while sleeping

  3. Diagnosis: Obstructive/Central/Complex Sleep Apnea CPAP- Continuous Positive Airway Pressure or Bi-PAP [ Time Frame: CPAP ordered at either at initial or subsequent office visit for a period of 96 months, or until patient left the practice, or until date of death ]
    Initiation, method of accustomization/desensitzation, duration of use, compliance, and reason for discontinuation

  4. Diagnosis: Bradycardia/tachycardia [ Time Frame: Recorded at all office visits or overnight testing for a period of 96 months, or until patient left the practice, or until date of death ]
    Heart rate under 60 or over 100 Correlation with rate control medications and acetylcholinesterase inhibitor

  5. Discontinuation of cognitively impairing medications or other high risk medications (Beers criteria): benzodiazepines, narcotics, anticholinergics, and antipsychotics [ Time Frame: At initial office visit and all subsequent visits for a period of 96 months, or until patient left the practice, or until date of death ]
    Class of drug, dose, date of discontinuation



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cohort 1: Consecutive patients presenting for care for cognitive impairment in a non-academic, non-hospital based, dementia specialty practice in Springfield, MA Cohort 2: Convenience sample of patients referred to neuropsychological testing and treated by non-dementia specialists in Springfield, MA
Criteria

Inclusion Criteria:

  • individuals presenting for assessment and treatment of cognitive impairment, either by self-identification, report by family or caregivers, or upon referral from another physician.

Exclusion Criteria:

  • individuals who were not fluent in English and for whom a translator was not available.
  • individuals who were blind

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860338


Sponsors and Collaborators
Clionsky Neuro Systems Inc.
Investigators
Principal Investigator: Emily F Clionsky, M.D. Clionsky Neuro Systems Inc.

Additional Information:
Publications:
Responsible Party: Clionsky Neuro Systems Inc.
ClinicalTrials.gov Identifier: NCT02860338     History of Changes
Other Study ID Numbers: CNS 2012-004
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Clionsky Neuro Systems Inc.:
Psuedobulbar affect, PBA

Additional relevant MeSH terms:
Dementia
Frontotemporal Dementia
Pick Disease of the Brain
Dementia, Vascular
Frontotemporal Lobar Degeneration
Parkinson Disease
Alzheimer Disease
Brain Injuries
Cognitive Dysfunction
Anemia, Iron-Deficiency
Hypoxia
Aphasia, Primary Progressive
Tauopathies
Vitamin B 12 Deficiency
Hyperhomocysteinemia
Lewy Body Disease
Neurodegenerative Diseases
TDP-43 Proteinopathies
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cognition Disorders