Clinical trial NCT02740634: Molecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study
Official title: Molecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atypical Alzheimer's Disease
Logopenic Progressive Aphasia (LPA)
Posterior Cortical Atrophy (PCA)
Alzheimer Disease
Alzheimer Disease, Early Onset
Amnestic Disorder
Amnestic Symptoms
Amnestic Mild Cognitive Disorder
Keywords: PCA
LPA
AD
Amnestic AD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2016-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with typical and atypical Alzheimer's Disease and how burden may change over a one year period.


Eligibility criteria: Inclusion Criteria:

* Over the age of 21
* Must have an informant who will be able to provide independent evaluation of functioning
* English is primary language
* All subjects must have insidious onset, report progression of their symptoms, and meet current clinical diagnostic criteria for typical amnestic AD or an atypical AD syndrome such as Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
* All subjects with Logopenic Aphasia (LPA) must present with early and dominant impairments in language
* All subjects with typical amnestic AD must have relative preservation of episodic memory compared to impairment in the non-episodic memory domain

Exclusion Criteria:

* If you have had a stroke or tumor that could explain your symptoms
* Subjects that present with early episodic memory impairment or meet clinical criteria for mild cognitive impairment will not be recruited into the study
* Subjects that meet specific criteria for another neurodegenerative disorder, including behavioral variant frontotemporal dementia, semantic dementia, primary progressive apraxia of speech, probable corticobasal syndrome, or progressive supranuclear palsy, will be excluded
* Subjects will be excluded if they have poor vision (20/400)
* Women that are pregnant or post-partum and breast-feeding will be excluded
* Subjects will be excluded from the study if they are unable to undergo the tau-PET scan due to a prolonged QT interval on ECG, or if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, and Down's syndrome
* Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism,(e.g. chemotherapy)

Primary outcomes:
measure: Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
timeFrame: 5 years
measure: Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
timeFrame: 5 years
Secondary outcomes:
measure: Rates of change in amyloid-PET burden over time.
timeFrame: baseline, 1 year
measure: Rates of change in tau-PET burden over time.
timeFrame: baseline, 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jennifer Whitwell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: