- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05122598
Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease
2022년 5월 12일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
200
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Evaristus Nwulia, MD
- 전화번호: 410-227-2005
- 이메일: enwulia@evonmedics.org
연구 연락처 백업
- 이름: Maria Hipolito, MD
- 전화번호: 571-241-2766
- 이메일: mhipolito@evonmedics.org
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20002
- 모병
- Clinics of Dr. Edwin Chapman @ MHDG
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연락하다:
- Edwin Chapman, MD
- 전화번호: 202-396-8550
- 이메일: echap1647@aol.com
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Washington, District of Columbia, 미국, 20020
- 모병
- Family and Medical Counseling Service, Inc
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연락하다:
- Michael Serlin, MD
- 전화번호: 573 202-889-7900
- 이메일: mserlin@fmcsinc.org]
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Washington, District of Columbia, 미국, 20060
- 모병
- Howard University (HU)
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연락하다:
- Thomas O Obisesan, MD
- 전화번호: 202-865-6100
- 이메일: tobisesan@howard.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
55년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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.
다른 이름들:
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가짜 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Logical Memory II subscale (Delayed Paragraph Recall)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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.
|
6 months
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ADCS-PACC composite score
기간: 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.
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9 months
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Olfactory Psychophysical Tasks scores
기간: 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
기간: 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
기간: 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.
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9 months
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Changes in cortical thickness and grey matter volumes
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Changes in the scores of Neuropsychological Test Battery (NTB)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
수사관
- 수석 연구원: Evaristus Nwulia, MD, Evon Medics LLC
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 11월 15일
기본 완료 (예상)
2023년 4월 1일
연구 완료 (예상)
2023년 4월 30일
연구 등록 날짜
최초 제출
2021년 9월 28일
QC 기준을 충족하는 최초 제출
2021년 11월 4일
처음 게시됨 (실제)
2021년 11월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 5월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 5월 12일
마지막으로 확인됨
2022년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- COTAG061981
- 2R44AG061981-03 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
COT에 대한 임상 시험
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University of California, San DiegoNational Cancer Institute (NCI); University of Michigan; Arizona State University; Small Steps...모병
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Toronto Rehabilitation InstituteThe Physicians' Services Incorporated Foundation; Christopher Reeve Paralysis Foundation완전한
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First Affiliated Hospital of Wenzhou Medical University모병
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