Dementia Clinical Trial
Official title:
Retrospective Analysis of the Comparative Effectiveness of MCI and Dementia Treatment Protocols in a Community-based Specialty Dementia Practice
Verified date | August 2016 |
Source | Clionsky Neuro Systems Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 900 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 90 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Clionsky Neuro Systems Inc. |
Clionsky M, Clionsky E. Psychometric equivalence of a paper-based and computerized (iPad) version of the Memory Orientation Screening Test (MOST®). Clin Neuropsychol. 2014;28(5):747-55. doi: 10.1080/13854046.2014.913686. Epub 2014 May 12. — View Citation
Clionsky MI, Clionsky E. Development and validation of the Memory Orientation Screening Test (MOSTâ„¢): A better screening test for dementia. Am J Alzheimers Dis Other Demen. 2010 Dec;25(8):650-6. doi: 10.1177/1533317510386216. — View Citation
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Medications - prescribed | 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 | No |
Other | Oxygen - prescribed | 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 | No |
Other | Diagnosis: Obstructive/Central/Complex Sleep Apnea CPAP- Continuous Positive Airway Pressure or Bi-PAP | 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 | No |
Other | Diagnosis: Bradycardia/tachycardia | 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 | No |
Other | Discontinuation of cognitively impairing medications or other high risk medications (Beers criteria): benzodiazepines, narcotics, anticholinergics, and antipsychotics | 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 | No |
Primary | Cognitive testing - Memory Orientation Screening Test (MOST) | At each office visit, for 96 months, until patient left the practice, or until date of death | No | |
Secondary | Resting and ambulatory pulse oximetry in office | 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 | No |
Secondary | Nocturnal pulse oximetry | 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. | No |
Secondary | Polysomnography in-lab and ambulatory ( in patient's residence) | 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. | No |
Secondary | 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 | No |
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