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Completed

NCT Number: NCT02860338

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

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Alzheimer's Disease Amino Acid Metabolism, Inborn Errors Anemia Arterial Occlusive Diseases Arteriosclerosis Avitaminosis Basal Ganglia Diseases Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Deficiency Diseases Dementia Dementia, Vascular Frontotemporal Dementia Frontotemporal Lobar Degeneration Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hyperhomocysteinemia Hypoxia Intracranial Arterial Diseases Intracranial Arteriosclerosis Iron Deficiencies Iron Deficiency Iron Metabolism Disorders Leukoencephalopathies Lewy Body Dementia Lewy Body Disease Malabsorption Syndromes Malnutrition Mental Disorders Metabolic Diseases Metabolism, Inborn Errors Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurodegenerative Disorders Nutrition Disorders Nutritional and Metabolic Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Signs and Symptoms, Respiratory Synucleinopathies TBI TDP-43 Proteinopathies Tauopathies Trauma, Nervous System Vascular Dementia Vascular Diseases Vitamin B 12 Deficiency Vitamin B Deficiency Wounds and Injuries

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Clionsky Neuro Systems Inc.

Industry

Registry information

Official study title

Retrospective Analysis of the Comparative Effectiveness of MCI and Dementia Treatment Protocols in a Community-based Specialty Dementia Practice

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 9, 2016
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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