An observational study in Mild Cognitive Impairment, Dementia and Hypoxia, sponsored by Clionsky Neuro Systems Inc.. Completed. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-09.
Sponsored by Clionsky Neuro Systems Inc. · 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.
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's enrollment of 900 is above the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Clionsky Neuro Systems Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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
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
Time frame: At each office visit, for 96 months, until patient left the practice, or until date of death
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
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.
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
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.
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
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
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
Oxygen - prescribed
Initiation, duration, and reason for discontinuation of O 2 nasal cannula supplementation either 24 x 7, or only while sleeping
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
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
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
Diagnosis: Bradycardia/tachycardia
Heart rate under 60 or over 100 Correlation with rate control medications and acetylcholinesterase inhibitor
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
Discontinuation of cognitively impairing medications or other high risk medications (Beers criteria): benzodiazepines, narcotics, anticholinergics, and antipsychotics
Class of drug, dose, date of discontinuation
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
No study locations are listed for this record.
Plan to share: No
The record gives a start of Jan 2009, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Clionsky Neuro Systems Inc.