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

NCT02860338 | Completed

• 1 other identifier: CNS 2012-004
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Psuedobulbar affect, PBA

Outcome Measures

Primary Outcomes (1)

• Cognitive testing - Memory Orientation Screening Test (MOST)

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

Secondary Outcomes (4)

• Resting and ambulatory pulse oximetry in office

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

• Nocturnal pulse oximetry

  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)

  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

  Ordered at initial and subsequent office visits for 96 months, until patient left the practice, or until date of death

Other Outcomes (5)

• Medications - prescribed

  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

  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

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clionsky Neuro Systems Inc.: lead

Related Publications (3)

• Clionsky MI, Clionsky E. Development and validation of the Memory Orientation Screening Test (MOST): A better screening test for dementia. Am J Alzheimers Dis Other Demen. 2010 Dec;25(8):650-6. doi: 10.1177/1533317510386216.

  PMID: 21131671 BACKGROUND

• The Memory Orientation Screening Test accurately separates Normal from MCI and Demented Elder in a prevalence-stratified sample. Journal of Alzheimer's Disease and Parkinsonism. 2013 vol 3(1). http://dx.doi,org/10.4172/2161-04601000109

  BACKGROUND

• Clionsky M, Clionsky E. Psychometric equivalence of a paper-based and computerized (iPad) version of the Memory Orientation Screening Test (MOST(R)). Clin Neuropsychol. 2014;28(5):747-55. doi: 10.1080/13854046.2014.913686. Epub 2014 May 12.

  PMID: 24815733 BACKGROUND

Related Links

• AAN 2014 moderator -presented poster

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Hypoxia; Hyperhomocysteinemia; Vitamin B 12 Deficiency; Iron Deficiencies; Anemia; Neurodegenerative Diseases; Alzheimer Disease; Dementia, Vascular; Brain Injuries; Tauopathies; Parkinson Disease; Lewy Body Disease; Frontotemporal Dementia; TDP-43 Proteinopathies

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Iron Metabolism Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; Proteostasis Deficiencies

Study Officials

• Emily F Clionsky, M.D.

  Clionsky Neuro Systems Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 9, 2016
• Study Start: January 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 9, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share