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

August 4, 2016 updated by: Clionsky Neuro Systems Inc.

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At each office visit, for 96 months, until patient left the practice, or until date of death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At each office visit, for 96 months, until patient left the practice, or until date of death
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
Ordered and Initial office visit or subsequent patient visits, for 96 months, until the patient left the practice, or until the date of death.
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
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.
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
Ordered at initial and subsequent office visits for 96 months, until patient left the practice, or until date of death

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clionsky Neuro Systems Inc.

Investigators

  • Principal Investigator: Emily F Clionsky, M.D., Clionsky Neuro Systems Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (ESTIMATE)

August 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNS 2012-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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