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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02740634
• Other study ID #: 15-008682
• Secondary ID: R01AG050603
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: Sarah M Boland, CCRP
• Phone: 507-284-3863
• Email: boland.sarah[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset
• Amnestic Disorder
• Aphasia
• Atypical Alzheimer's Disease
• Cognition Disorders
• Cognitive Dysfunction
• Logopenic Progressive Aphasia (LPA)
• Posterior Cortical Atrophy (PCA)

Intervention

Drug:
• F-18 AV 1451
Tau binding agent
• C-11 PiB
Amyloid binding agent

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).		5 years
Primary	Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).		5 years
Secondary	Rates of change in amyloid-PET burden over time.		baseline, 1 year
Secondary	Rates of change in tau-PET burden over time.		baseline, 1 year

External Links

•   Mayo Clinic Clinical Trials