Alzheimer DiseaseNCT05019014
Olfactory Deficits in Neurologic Disease
An observational study of Alzheimer Disease and Traumatic Brain Injury, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Traumatic Brain Injury, Amyotrophic Lateral Sclerosis
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2011to 3 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Pneumocephalus
- Basilar skull fracture
- Known CSF leak
- Facial fractures to include Lefort I, II or III
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
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).
Read the 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.
- Conditions
- Alzheimer Disease, Traumatic Brain Injury, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Lewy Body Disease, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Brain Injuries, Traumatic, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Lewy Body Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Selective loss of episodic odor memory (Poor POEM status) will correlate with imaging and neuropsychological signs of neurodegenerative disease.
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.
Measured: 9 years
Secondary outcomes (3)
Correct responses on the episodic memory of odor percepts measure will correlate with entorhinal cortical thickness, and neuropsychological test results.
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.
Measured: 9 years
Correct responses on the odor percept identification task will correlate with imaging and neuropsychological signs of neurodegenerative disease.
Compare number of trials of odors correctly identified will correlate with entorhinal cortical thickness, and neuropsychological test results.
Measured: 9 years
Correct responses on the odor discrimination task will correlate with imaging and neuropsychological signs of neurodegenerative disease.
Compare number of trials correctly discriminated will correlate with entorhinal cortical thickness, and neuropsychological test results.
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start10 Aug 2011
- Primary completion3 Jan 2017
- Study completion3 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark William Albers, Massachusetts General Hospital
- Investigators
- Mark W Albers, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019014
- Sponsor's protocol ID
- 2011P001296
- Status last verified
- Aug 2021
- First submitted
- 7 Apr 2017
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dhilla Albers A, Asafu-Adjei J, Delaney MK, Kelly KE, Gomez-Isla T, Blacker D, Johnson KA, Sperling RA, Hyman BT, Betensky RA, Hastings L, Albers MW. Episodic memory of odors stratifies Alzheimer biomarkers in normal elderly. Ann Neurol. 2016 Dec;80(6):846-857. doi: 10.1002/ana.24792. Epub 2016 Nov 23.
PubMed 27696605
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Deficits in Neurologic Disease
- ClinicalTrials.gov ID
- NCT05019014
- Acronym / sponsor ID
- 2011P001296
- Conditions
- Alzheimer Disease, Traumatic Brain Injury, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Lewy Body Disease, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Aug 2011 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Correct responses on the episodic memory of odor percepts measure will correlate with entorhinal cortical thickness, and neuropsychological test results.
Time frame: 9 years
Correct responses on the odor percept identification task will correlate with imaging and neuropsychological signs of neurodegenerative disease.
Time frame: 9 years
Correct responses on the odor discrimination task will correlate with imaging and neuropsychological signs of neurodegenerative disease.
Time frame: 9 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 27696605Dhilla Albers A, Asafu-Adjei J, Delaney MK, Kelly KE, Gomez-Isla T, Blacker D, Johnson KA, Sperling RA, Hyman BT, Betensky RA, Hastings L, Albers MW. Episodic memory of odors stratifies Alzheimer biomarkers in normal elderly. Ann Neurol. 2016 Dec;80(6):846-857. doi: 10.1002/ana.24792. Epub 2016 Nov 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark W Albers, MD PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Traumatic Brain Injury, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective loss of episodic odor memory (Poor POEM status) will correlate with imaging and neuropsychological signs of neurodegenerative disease. (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.