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

2022年5月12日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (予想される)

200

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • District of Columbia
      • Washington、District of Columbia、アメリカ、20002
        • 募集
        • Clinics of Dr. Edwin Chapman @ MHDG
        • コンタクト：
      • Washington、District of Columbia、アメリカ、20020
        • 募集
        • Family and Medical Counseling Service, Inc
        • コンタクト：
      • Washington、District of Columbia、アメリカ、20060
        • 募集
        • Howard University (HU)
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

55年～95年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
薬：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.
他の名前：
  • COT with olfactory stimulants
偽コンパレータ：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.
薬：Sham
Sham COT uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks.
他の名前：
  • Sham COT

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Logical Memory II subscale (Delayed Paragraph Recall)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline and 9 months
Using the Automatic Segmentation of Hippocampal subfields looking for changes in the hippocampus and entorhinal cortex
Baseline and 9 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Changes in the scores of Neuropsychological Test Battery (NTB)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, 9 months
Primary olfactory region images will use MPRAGE MRI sequence for cortical thickness
Baseline, 9 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Evon Medics LLC

協力者

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

捜査官

  • 主任研究者：Evaristus Nwulia, MD、Evon Medics LLC

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年11月15日

一次修了 (予想される)

2023年4月1日

研究の完了 (予想される)

2023年4月30日

試験登録日

最初に提出

2021年9月28日

QC基準を満たした最初の提出物

2021年11月4日

最初の投稿 (実際)

2021年11月17日

学習記録の更新

投稿された最後の更新 (実際)

2022年5月17日

QC基準を満たした最後の更新が送信されました

2022年5月12日

最終確認日

2022年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • COTAG061981
  • 2R44AG061981-03 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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