Alzheimer Disease Clinical Trial
Official title:
Olfactory Deficits in Neurologic Disease
NCT number | NCT05019014 |
Other study ID # | 2011P001296 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 10, 2011 |
Est. completion date | July 3, 2020 |
Verified date | August 2021 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 201 |
Est. completion date | July 3, 2020 |
Est. primary completion date | January 3, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 9 years | |
Secondary | 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. | 9 years | |
Secondary | 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. | 9 years | |
Secondary | 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. | 9 years |
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