NCT05019014|Completed
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Sponsor study identifier
observational
201
1 country
1
Study Start
August 10, 2011
Actual (reported)Primary Completion
January 3, 2017
Actual (reported)Study Completion
July 3, 2020
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 3, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 10, 2011
Actual (reported)January 3, 2017
Actual (reported)April 7, 2017
Actual (reported)July 3, 2020
Actual (reported)August 24, 2021
Actual (reported)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
Correct responses on the episodic memory of odor percepts measure will correlate with entorhinal cortical thickness, and neuropsychological test results.
9 years
Correct responses on the odor percept identification task will correlate with imaging and neuropsychological signs of neurodegenerative disease.
9 years
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.
Healthy participants with no diagnosis.
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.
Massachusetts General Hospital
Boston, Massachusetts, 02129, 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.
Mark W Albers, MD PhD
Massachusetts General Hospital
201 participants (actual enrollment reported by the registry).
First Submitted
April 7, 2017
First Posted
August 24, 2021
Study Start
August 10, 2011
Actual (reported)PRISM Registry: Pseudobulbar Affect Registry Series
Correct responses on the odor discrimination task will correlate with imaging and neuropsychological signs of neurodegenerative disease.
9 years
Contact the study team to confirm eligibility.
Primary Completion
January 3, 2017
Actual (reported)Study Completion
July 3, 2020
Actual (reported)Last Updated
August 24, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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