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

Not Applicable

Recruiting

• Conditions: Amnestic Mild Cognitive Disorder; Atypical Alzheimer's Disease; Amnestic Disorder; Alzheimer Disease; Alzheimer Disease, Early Onset; Logopenic Progressive Aphasia (LPA); Posterior Cortical Atrophy (PCA); Amnestic Symptoms
• Interventions: Drug: F-18 AV 1451; Drug: C-11 PiB

• Registration Number: NCT02740634
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Study Start: 2016-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tau PET Scan, F-18 AV 1451	C-11 PiB	All subjects will receive two Tau PET scans during this study.
Tau PET Scan, F-18 AV 1451	F-18 AV 1451	All subjects will receive two Tau PET scans during this study.
PiB PET Scan, C-11 PiB	C-11 PiB	All subjects will receive two PiB PET scans during this study.
PiB PET Scan, C-11 PiB	F-18 AV 1451	All subjects will receive two PiB PET scans during this study.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rates of change in amyloid-PET burden over time.	baseline, 1 year
Rates of change in tau-PET burden over time.	baseline, 1 year

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States