Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- AROMHA Brain Health Test
研究概览
简要总结
The goal of this study is to objectively test one's sense of smell, called olfaction, in participants with Subjective Cognitive Concerns (SCC), Mild Cognitive Impairment, Mild Behavioral Impairment (MBI), and age-matched controls. The main question it aims to answer is whether the AROMHA Brain Health Test could serve as a predictive biomarker of neurodegenerative disorders. This understanding will aid in the development of a noninvasive, cost-effective diagnostic tool that reliably and specifically distinguishes disease and normal aging populations.
Participants will take the approximately 45-minute AROMHA Brain Health Smell Test where they will peel and sniff labels on the physical smell cards and answer questions on the web-based app relating to what they smelled. Participants will undergo tests for odor intensity, odor identification, odor discrimination, and episodic olfactory memory, but will not be provided the results of these tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A clinical or research consensus diagnosis of the patient's condition or control status.
- •Individuals that are at least 18 years of age at the time of enrollment.
- •Individuals that are no older than 100 years of age at the time of enrollment.
排除标准
- •Primary pulmonary disease such as severe emphysema or asthma not under good medical control.
- •Current sinusitis, common cold, upper respiratory infection, or nasal polyps.
- •Current or recent (past 6 months) alcohol or substance dependence. A prior history of alcohol or substance abuse will not be grounds for exclusion.
- •Pregnancy.
- •Severe cognitive dysfunction that would preclude completion of the olfactory testing.
- •An adverse reaction to fragrances (ie. they trigger a severe asthmatic attack or nausea).
研究组 & 干预措施
Subjective Cognitive Concerns (SCC)
The composition of the proposed study population will reflect that of subjects recruited through the Longitudinal Cohort of the Massachusetts Alzheimer's Disease Research Center and that of patients treated by neurologists at the Memory and Movement Disorders Clinics at MGH as well as participants from the community.
干预措施: AROMHA Brain Health Test (Device)
Mild Cognitive Impairment (MCI)
The composition of the proposed study population will reflect that of subjects recruited through the Longitudinal Cohort of the Massachusetts Alzheimer's Disease Research Center and that of patients treated by neurologists at the Memory and Movement Disorders Clinics at MGH as well as participants from the community.
干预措施: AROMHA Brain Health Test (Device)
Mild Behavioral Impairment [prominent apathy] (MBI)
The composition of the proposed study population will reflect that of subjects recruited through the Longitudinal Cohort of the Massachusetts Alzheimer's Disease Research Center and that of patients treated by neurologists at the Memory and Movement Disorders Clinics at MGH as well as participants from the community.
干预措施: AROMHA Brain Health Test (Device)
Age-matched Controls
We will utilize community sampling to recruit 100 age-matched controls.
干预措施: AROMHA Brain Health Test (Device)
结局指标
主要结局
AROMHA Brain Health Test
时间窗: 1 hour
The AROMHA Brain Health Test is a battery of 18 odors across 5 smell cards. The subject smells each odor label and is tested on odor intensity, identification, memory, and discrimination. An increased number of correct responses indicates a better sense of smell. We will evaluate MCI patients' performance against age-matched controls.
次要结局
- AROMHA Brain Health Test(1 hour)
研究者
Mark W Albers
Frank Wilkens and Family Endowed Scholar/ Asst. Prof. Neurology
Massachusetts General Hospital