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Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease

12. mai 2022 oppdatert av: Evon Medics LLC

Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)

The purpose of this study is to determine whether daily treatment with this new treatment approach, called COT would be effective in protecting the memory and brain regions of people who are already showing signs of memory loss.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Alzheimer's disease process starts in parts of the brain used for perceiving and interpreting smell many years before people begin to lose their memory and other cognitive functions. These parts of the brain are called the "olfactory regions." From these olfactory regions, Alzheimer's disease spread to involve other parts of the brain. Scientists have shown that stimulating the olfactory regions through exposure to multiple naturally occurring essential or plant oils help to reduce the brain changes of Alzheimer's disease in animals. Also, many components from these plant oils have been shown to protect nerve cells from various kinds of stress and injuries; and we say they are 'neuroprotective'. A novel home-based olfactory chemosensory stimulation program that uses a portable, programmed, device known as the Computerized Olfactory Training (COT) program, administers olfactory psychophysical tasks while patients are being stimulated repeatedly with neuroprotective olfactory stimulants, using neuroscience-guided stimulation parameters to ensure sustained activation of all primary and secondary olfactory structures.

Studietype

Intervensjonell

Registrering (Forventet)

200

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20002
        • Rekruttering
        • Clinics of Dr. Edwin Chapman @ MHDG
        • Ta kontakt med:
      • Washington, District of Columbia, Forente stater, 20020
        • Rekruttering
        • Family and Medical Counseling Service, Inc
        • Ta kontakt med:
      • Washington, District of Columbia, Forente stater, 20060
        • Rekruttering
        • Howard University (HU)
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år til 95 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 55-95 years; female must be post-menopausal for ≥ 2 consecutive years
  2. Probable mild AD according to the core clinical criteria outlined in the National Institute on Aging/Alzheimer's Association (NIA-AA) Guidelines
  3. MMSE score between the range of 21 to 27; CDR score of 1.0 (mild AD); scores on Logical Memory II subscale (Delayed Recall) from the Wechsler Memory Scale-Revised (WMS) within the recommended education-adjusted ranges
  4. Have either cerebrospinal fluid (CSF) Aβ42 levels that are consistent with Alzheimer's disease as measured via mass spectrometry by C2N, or document elevated amyloid burden consistent with Alzheimer's disease from positron emission tomography (PET) imaging
  5. Screening MRI without evidence of infection, infarction, or other focal lesions of neurological disease; and no significant nasal disease.
  6. All participants must have a study partner with normal cognitive function.

Exclusion Criteria:

  1. Any significant neurologic disease
  2. Major psychiatric disorder within the past 2 years
  3. Substance use disorder within the past 2 years
  4. Any unstable medical condition
  5. Contraindications to MRI
  6. Any Alzheimer's disease modifying therapy (DMT) in the past 6 months
  7. Antipsychotics, anticholinergics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications and blood thinners, except for aspirin at a prophylactic dose or less.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Computerized Olfactory Training (COT) Device with olfactory stimulants
COT device with olfactory stimulants consists of daily 40 cycles of intervention with a combination of olfactory stimulation and training tasks, lasting ~45 minutes, delivered once daily over 6 months period by the participant or their partner/caregiver.
Legemiddel: COT
The COT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks.
Andre navn:
  • COT with olfactory stimulants
Sham-komparator: Sham/COT Device
This is COT device that uses compressed room air scented with phenylethylamine (rose scent) instead of olfactory stimulants and has shape pattern matching tasks instead of cognitive tasks, in order to blind users to their treatment assignment. Similar to the COT, sham COT will be used daily for 45 minutes.
Legemiddel: Sham
Sham COT uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks.
Andre navn:
  • Sham COT

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Logical Memory II subscale (Delayed Paragraph Recall)
Tidsramme: Baseline
Measures patient's ability to recall information after a 20 to 30 minutes delay for story b from the Wechsler Memory Scale-IV (0-25). Higher scores indicate better performance. This is use for evaluation of forgetting or memory decay.
Baseline
Logical Memory II subscale (Delayed Paragraph Recall)
Tidsramme: 6 months
Measures patient's ability to recall information after a 20 to 30 minutes delay for story b from the Wechsler Memory Scale-IV (0-25). Higher scores indicate better performance. This is use for evaluation of forgetting or memory decay.
6 months
Logical Memory II subscale (Delayed Paragraph Recall)
Tidsramme: 9 months
Measures patient's ability to recall information after a 20 to 30 minutes delay for story b from the Wechsler Memory Scale-IV (0-25). Higher scores indicate better performance. This is use for evaluation of forgetting or memory decay.
9 months
ADCS-PACC composite score
Tidsramme: Baseline
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Baseline
ADCS-PACC composite score
Tidsramme: 6 months
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
6 months
ADCS-PACC composite score
Tidsramme: 9 months
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
9 months
Olfactory Psychophysical Tasks scores
Tidsramme: Baseline
Using Sniffin' sticks, defines patient's olfactory threshold (T), discrimination (D) and identification (I). Scores: Male and Female threshold score (1-16); Male and Female discrimination score (4-16); Identification score (male: 3-16; female: 4-16); Threshold Discrimination Identification (TDI) composite score (male: 9-44; female: 11-43). Higher score indicates better olfactory performance.
Baseline
Olfactory Psychophysical Tasks scores
Tidsramme: 6 months
Using Sniffin' sticks, defines patient's olfactory threshold (T), discrimination (D) and identification (I). Scores: Male and Female threshold score (1-16); Male and Female discrimination score (4-16); Identification score (male: 3-16; female: 4-16); TDI composite score (male: 9-44; female: 11-43). Higher score indicates better olfactory performance.
6 months
Olfactory Psychophysical Tasks scores
Tidsramme: 9 months
Using Sniffin' sticks, defines patient's olfactory threshold (T), discrimination (D) and identification (I). Scores: Male and Female threshold score (1-16); Male and Female discrimination score (4-16); Identification score (male: 3-16; female: 4-16); TDI composite score (male: 9-44; female: 11-43). Higher score indicates better olfactory performance.
9 months
Changes in cortical thickness and grey matter volumes
Tidsramme: Baseline and 9 months
Defines as MRI imaging changes of the hippocampus and entorhinal cortex
Baseline and 9 months
Changes in subfield segmentations of the hippocampus and entorhinal cortex
Tidsramme: Baseline and 9 months
Using the Automatic Segmentation of Hippocampal subfields looking for changes in the hippocampus and entorhinal cortex
Baseline and 9 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in the scores of Neuropsychological Test Battery (NTB)
Tidsramme: Baseline, 6 months and 9 months
Neuropsychological Test Battery (NTB) is a combination of widely used clinical neuropsychological tests measuring memory and executive function. he total Neuropsychological Test Battery (NTB) executive function is a composite score obtained from averaging the following three z-scores from the NTB: Wechsler Memory Scale Digit Span, Controlled Word Association Test (COWAT), and Category Fluency Test (CFT). The range in z scores is from -3 to 3; higher scores indicating less executive function deficit.
Baseline, 6 months and 9 months
Changes in the scores of Mini Mental State Examination (MMSE)
Tidsramme: Baseline, 6 months and 9 months
Mini Mental State Examination (MMSE) measures cognitive function and includes tests of orientation, attention, memory, language and visual-spatial skills. MMSE range 0 - 30; higher scores indicating less deficit.
Baseline, 6 months and 9 months
Changes in the scores of CDR scale (CDR)
Tidsramme: Baseline, 6 months and 9 months

Clinical Dementia Rating Scale (CDR) is a 5- point scale used to characterize six domains of cognitive and functional performance (Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care) applicable to Alzheimer's disease and related dementias.

CDR Score is the sum of boxes scores range from 0 - 18; higher scores indicating worse deficit.
Baseline, 6 months and 9 months
Changes in the scores of Global Deterioration Scale(GDS)
Tidsramme: Baseline, 6 months and 9 months
GDS provides an overview of the stages of cognitive function for those suffering from primary degenerative dementia such as Alzheimer's disease. Geriatric Depression Scale (GDS) scores range from 0 - 30; higher scores indicating worse depression.
Baseline, 6 months and 9 months
Changes in the scores of Activities of Daily Living (ADCS-ADL)
Tidsramme: Baseline, 6 months and 9 months
ADCS-ADL is used for assessment of patient's ability to perform activities of daily living. ADCS-ADL is a 23-item activities of daily with score range from 0 - 78; lower scores indicating greater impairment.
Baseline, 6 months and 9 months
Changes in the scores of Quality of Life scale (QOL)
Tidsramme: Baseline, 6 months and 9 months
QOL measures satisfaction, perceptions of control, involvement, commitment and work-life balance, in terms of one's personal perception. QOL-AD score ranges from 13 - 52; higher scores indicating less deficit.
Baseline, 6 months and 9 months
Changes in odor discrimination scores
Tidsramme: Baseline, 9 months
Odor discrimination score defines patient's ability to detect differences between odors.
Baseline, 9 months
Changes in the grey matter volumes of other structures of the primary olfactory cortex
Tidsramme: Baseline, 9 months
Primary olfactory region images will use MPRAGE MRI sequence for grey matter volume
Baseline, 9 months
Changes in the cortical thickness of other structures of the primary olfactory cortex
Tidsramme: Baseline, 9 months
Primary olfactory region images will use MPRAGE MRI sequence for cortical thickness
Baseline, 9 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Evon Medics LLC

Samarbeidspartnere

Johns Hopkins University
National Institute on Aging (NIA)
Howard University
Medical Home Development Group
Family and Medical Counseling Service, Inc

Etterforskere

  • Hovedetterforsker: Evaristus Nwulia, MD, Evon Medics LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. november 2021

Primær fullføring (Forventet)

1. april 2023

Studiet fullført (Forventet)

30. april 2023

Datoer for studieregistrering

Først innsendt

28. september 2021

Først innsendt som oppfylte QC-kriteriene

4. november 2021

Først lagt ut (Faktiske)

17. november 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • COTAG061981
  • 2R44AG061981-03 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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