Olfactory Deficits in Neurologic Disease

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05019014

Collaborator

(none)

201

Enrollment

Location

106.8

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to examine olfactory function in preclinical subjects or individuals with neurological diseases such as Probable Alzheimer's Disease (PRAD), Frontotemporal Dementias (FTD), Dementia with Lewy Bodies (DLB), Traumatic Brain Injury (TBI), and Amyotrophic Lateral Sclerosis (ALS).

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Traumatic Brain Injury Amyotrophic Lateral Sclerosis Frontotemporal Dementia Lewy Body Disease Mild Cognitive Impairment

Detailed Description

The goal of this study is to examine olfactory function in preclinical subjects [n = 150] or individuals with neurological diseases such as Probable Alzheimer's Disease (PRAD) [n = 50], Mild Cognitive Impairment [n = 50], Frontotemporal Dementias (FTD) [n = 50], and Dementia with Lewy Bodies (DLB) [n = 50] that are part of the Longitudinal Research Cohort of the Massachusetts Alzheimer's Disease Research Center (IRB Protocol #: 1999P003693), are being treated by neurologists in the Memory Disorders or Movements Disorders Clinics at MGH, or are part of the community. The investigators will also examine individuals with Amyotrophic Lateral Sclerosis (ALS) [n = 50], ALS probands [n = 50], and ALS family controls [n = 50] that are part of the Neurological Clinical Research Institute (NCRI) protocols "NeuroBANK" (2013P001670), "Repository" (2006P000982), and "Longitudinal CSF" (2011P000785). Olfactory data will be correlated with existing data collected under the above-mentioned IRB protocols. The investigators will also be studying olfactory function in patients with mild TBI [n=50], and moderate and severe TBI [n=50], that are patients of Spaulding Rehabilitation Network. Specifically, the investigators will assess odor discrimination, odor identification, and episodic olfactory memory, using the OLFACT olfactometer run by a laptop or through a wireless iPad interface (Osmic Enterprises). Olfactory data collected from patients and age-matched control subjects [n = 100] will be correlated with existing structural MRI, functional MRI, and PET imaging data and with existing neuropsychological data collected under IRB protocols 1999P003693 and 2007P002107 ("Neurological Disease Registry"), NeuroBANK™ IRB protocol 2013P001670, Repository IRB protocol 2006P000982, and Longitudinal CSF IRB protocol 2011P000785.

Study Design

Study Type:

Observational

Actual Enrollment :

201 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Olfactory Deficits in Neurologic Disease

Actual Study Start Date :

Aug 10, 2011

Actual Primary Completion Date :

Jan 3, 2017

Actual Study Completion Date :

Jul 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Neurodegenerative disease Participants with a diagnosis of Probable Alzheimer's Disease, prodromal Alzheimer's Disease, Frontotemporal Dementia, Mild Cognitive Impairment, Dementia with Lewy Bodies, mild and moderate/severe TBI, and familial or sporadic ALS per El Escorial Criteria or individuals with known gene mutations associated with ALS.
Age-matched controls Healthy participants with no diagnosis.

Outcome Measures

Primary Outcome Measures

Selective loss of episodic odor memory (Poor POEM status) will correlate with imaging and neuropsychological signs of neurodegenerative disease. [9 years]
Poor POEM status determined by comparing the predicted POEM score with the actual POEM score will correlate with entorhinal cortical thickness, and neuropsychological test results.

Secondary Outcome Measures

Correct responses on the episodic memory of odor percepts measure will correlate with entorhinal cortical thickness, and neuropsychological test results. [9 years]
Compare number of trials correctly discriminated; compare number of odors correctly identified; and compare number of hits (accurate episodic memory of exposure to odor), and number of correct rejections (accurate episodic memory of non-exposure to odor). Correlate familiarity with number of hits and correct rejections.
Correct responses on the odor percept identification task will correlate with imaging and neuropsychological signs of neurodegenerative disease. [9 years]
Compare number of trials of odors correctly identified will correlate with entorhinal cortical thickness, and neuropsychological test results.
Correct responses on the odor discrimination task will correlate with imaging and neuropsychological signs of neurodegenerative disease. [9 years]
Compare number of trials correctly discriminated will correlate with entorhinal cortical thickness, and neuropsychological test results.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnosis of Probable Alzheimer's Disease, prodromal Alzheimer's Disease, Frontotemporal Dementia, Mild Cognitive Impairment, or Dementia with Lewy Bodies or mild and moderate/severe TBI.
Diagnosis of familial or sporadic ALS per El Escorial Criteria or individuals with known gene mutations associated with ALS (regardless of clinical phenotype).
Age-matched controls
Males and females with a minimum age of enrollment of 18 years. There is no maximum age of enrollment.

Exclusion Criteria:

Primary pulmonary disease such as severe emphysema or asthma not under good medical control.
Current sinusitis or common cold or upper respiratory infection, nasal polyps, or sinusitis.
Traumatic or congenital anosmia
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
Pneumocephalus
Basilar skull fracture
Known CSF leak
Facial fractures to include Lefort I, II or III