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Recruiting NCT02740634

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

No phase Interventional Atypical Alzheimer's Disease Logopenic Progressive Aphasia (LPA) Posterior Cortical Atrophy (PCA) Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: F-18 AV 1451, C-11 PiB.
Who it may be relevant to
Registry conditions: Atypical Alzheimer's Disease, Logopenic Progressive Aphasia (LPA), Posterior Cortical Atrophy (PCA), Alzheimer Disease. Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA). [Time frame: 5 years]
  • Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA). [Time frame: 5 years]
Secondary outcome measures (2)
  • Rates of change in amyloid-PET burden over time. [Time frame: baseline, 1 year]
  • Rates of change in tau-PET burden over time. [Time frame: baseline, 1 year]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT02740634 · 15-008682 · R01AG050603

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗