Molecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study

Mayo Clinic

Status: Enrolling

Conditions: Alzheimer Disease; Amnestic Mild Cognitive Disorder; Posterior Cortical Atrophy (PCA); Atypical Alzheimer's Disease; Logopenic Progressive Aphasia (LPA); Amnestic Disorder; Amnestic Symptoms; Alzheimer Disease, Early Onset

Treatments: Drug: C-11 PiB; Drug: F-18 AV 1451

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02740634

15-008682

R01AG050603 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Tau PET Scan, F-18 AV 1451

Experimental group

Description:

All subjects will receive two Tau PET scans during this study.

Treatment:

Drug: F-18 AV 1451

Drug: C-11 PiB

PiB PET Scan, C-11 PiB

Experimental group

Description:

All subjects will receive two PiB PET scans during this study.

Treatment:

Drug: F-18 AV 1451

Drug: C-11 PiB