- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05122598
Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Evaristus Nwulia, MD
- Numero di telefono: 410-227-2005
- Email: enwulia@evonmedics.org
Backup dei contatti dello studio
- Nome: Maria Hipolito, MD
- Numero di telefono: 571-241-2766
- Email: mhipolito@evonmedics.org
Luoghi di studio
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20002
- Reclutamento
- Clinics of Dr. Edwin Chapman @ MHDG
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Contatto:
- Edwin Chapman, MD
- Numero di telefono: 202-396-8550
- Email: echap1647@aol.com
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Washington, District of Columbia, Stati Uniti, 20020
- Reclutamento
- Family and Medical Counseling Service, Inc
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Contatto:
- Michael Serlin, MD
- Numero di telefono: 573 202-889-7900
- Email: mserlin@fmcsinc.org]
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Washington, District of Columbia, Stati Uniti, 20060
- Reclutamento
- Howard University (HU)
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Contatto:
- Thomas O Obisesan, MD
- Numero di telefono: 202-865-6100
- Email: tobisesan@howard.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 55-95 years; female must be post-menopausal for ≥ 2 consecutive years
- Probable mild AD according to the core clinical criteria outlined in the National Institute on Aging/Alzheimer's Association (NIA-AA) Guidelines
- 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
- 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
- Screening MRI without evidence of infection, infarction, or other focal lesions of neurological disease; and no significant nasal disease.
- All participants must have a study partner with normal cognitive function.
Exclusion Criteria:
- Any significant neurologic disease
- Major psychiatric disorder within the past 2 years
- Substance use disorder within the past 2 years
- Any unstable medical condition
- Contraindications to MRI
- Any Alzheimer's disease modifying therapy (DMT) in the past 6 months
- Antipsychotics, anticholinergics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications and blood thinners, except for aspirin at a prophylactic dose or less.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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.
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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.
Altri nomi:
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Comparatore fittizio: 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.
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Sham COT uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Logical Memory II subscale (Delayed Paragraph Recall)
Lasso di tempo: Baseline
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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.
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Baseline
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Logical Memory II subscale (Delayed Paragraph Recall)
Lasso di tempo: 6 months
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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.
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6 months
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Logical Memory II subscale (Delayed Paragraph Recall)
Lasso di tempo: 9 months
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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.
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9 months
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ADCS-PACC composite score
Lasso di tempo: Baseline
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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.
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Baseline
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ADCS-PACC composite score
Lasso di tempo: 6 months
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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.
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6 months
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ADCS-PACC composite score
Lasso di tempo: 9 months
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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.
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9 months
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Olfactory Psychophysical Tasks scores
Lasso di tempo: Baseline
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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.
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Baseline
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Olfactory Psychophysical Tasks scores
Lasso di tempo: 6 months
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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.
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6 months
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Olfactory Psychophysical Tasks scores
Lasso di tempo: 9 months
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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.
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9 months
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Changes in cortical thickness and grey matter volumes
Lasso di tempo: Baseline and 9 months
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Defines as MRI imaging changes of the hippocampus and entorhinal cortex
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Baseline and 9 months
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Changes in subfield segmentations of the hippocampus and entorhinal cortex
Lasso di tempo: Baseline and 9 months
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Using the Automatic Segmentation of Hippocampal subfields looking for changes in the hippocampus and entorhinal cortex
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Baseline and 9 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes in the scores of Neuropsychological Test Battery (NTB)
Lasso di tempo: Baseline, 6 months and 9 months
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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.
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Baseline, 6 months and 9 months
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Changes in the scores of Mini Mental State Examination (MMSE)
Lasso di tempo: Baseline, 6 months and 9 months
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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.
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Baseline, 6 months and 9 months
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Changes in the scores of CDR scale (CDR)
Lasso di tempo: Baseline, 6 months and 9 months
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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
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Changes in the scores of Global Deterioration Scale(GDS)
Lasso di tempo: Baseline, 6 months and 9 months
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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.
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Baseline, 6 months and 9 months
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Changes in the scores of Activities of Daily Living (ADCS-ADL)
Lasso di tempo: Baseline, 6 months and 9 months
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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.
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Baseline, 6 months and 9 months
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Changes in the scores of Quality of Life scale (QOL)
Lasso di tempo: Baseline, 6 months and 9 months
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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.
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Baseline, 6 months and 9 months
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Changes in odor discrimination scores
Lasso di tempo: Baseline, 9 months
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Odor discrimination score defines patient's ability to detect differences between odors.
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Baseline, 9 months
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Changes in the grey matter volumes of other structures of the primary olfactory cortex
Lasso di tempo: Baseline, 9 months
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Primary olfactory region images will use MPRAGE MRI sequence for grey matter volume
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Baseline, 9 months
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Changes in the cortical thickness of other structures of the primary olfactory cortex
Lasso di tempo: Baseline, 9 months
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Primary olfactory region images will use MPRAGE MRI sequence for cortical thickness
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Baseline, 9 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Evaristus Nwulia, MD, Evon Medics LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Disturbi neurocognitivi
- Malattie Neurodegenerative
- Demenza
- Tauopatie
- Disturbi cognitivi
- Malattia di Alzheimer
- Disfunzione cognitiva
- Effetti fisiologici delle droghe
- Stimolanti del sistema nervoso centrale
Altri numeri di identificazione dello studio
- COTAG061981
- 2R44AG061981-03 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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