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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease; Alzheimer Disease, Early Onset; Amnestic Mild Cognitive Disorder; Atypical Alzheimer's Disease; Logopenic Progressive Aphasia (LPA); Posterior Cortical Atrophy (PCA); Amnestic Disorder; Amnestic Symptoms
• Intervention / Treatment: Drug: F-18 AV 1451; Drug: C-11 PiB

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tau PET Scan, F-18 AV 1451; All subjects will receive two Tau PET scans during this study.	Drug: F-18 AV 1451; Tau binding agent; Drug: C-11 PiB; Amyloid binding agent
Experimental: PiB PET Scan, C-11 PiB; All subjects will receive two PiB PET scans during this study.	Drug: F-18 AV 1451; Tau binding agent; Drug: C-11 PiB; Amyloid binding agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).	5 years
Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of change in tau-PET burden over time.	baseline, 1 year
Rates of change in amyloid-PET burden over time.	baseline, 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jennifer Whitwell, Ph.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimated): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PCA; AD; LPA; Amnestic AD
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole
• Other Study ID Numbers: 15-008682; R01AG050603 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No