Olfactory Deficits in Neurologic Disease

August 18, 2021 updated by: Mark William Albers, Massachusetts General Hospital
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. 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.
  2. Diagnosis of familial or sporadic ALS per El Escorial Criteria or individuals with known gene mutations associated with ALS (regardless of clinical phenotype).
  3. Age-matched controls
  4. Males and females with a minimum age of enrollment of 18 years. There is no maximum age of enrollment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Selective loss of episodic odor memory (Poor POEM status) will correlate with imaging and neuropsychological signs of neurodegenerative disease.
Time Frame: 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.
9 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correct responses on the episodic memory of odor percepts measure will correlate with entorhinal cortical thickness, and neuropsychological test results.
Time Frame: 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.
9 years
Correct responses on the odor percept identification task will correlate with imaging and neuropsychological signs of neurodegenerative disease.
Time Frame: 9 years
Compare number of trials of odors correctly identified will correlate with entorhinal cortical thickness, and neuropsychological test results.
9 years
Correct responses on the odor discrimination task will correlate with imaging and neuropsychological signs of neurodegenerative disease.
Time Frame: 9 years
Compare number of trials correctly discriminated will correlate with entorhinal cortical thickness, and neuropsychological test results.
9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011P001296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings