NCT02740634

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
May 2016Mar 2027

First Submitted

Initial submission to the registry

April 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

10.8 years

First QC Date

April 7, 2016

Last Update Submit

April 7, 2026

Conditions

Alzheimer DiseaseAtypical Alzheimer's DiseaseLogopenic Progressive Aphasia (LPA)Posterior Cortical Atrophy (PCA)Alzheimer Disease, Early OnsetAmnestic DisorderAmnestic SymptomsAmnestic Mild Cognitive Disorder

Keywords

PCALPAADAmnestic AD

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Rates of change in amyloid-PET burden over time.

    baseline, 1 year

  • Rates of change in tau-PET burden over time.

    baseline, 1 year

Study Arms (2)

Tau PET Scan, F-18 AV 1451

EXPERIMENTAL

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

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

PiB PET Scan, C-11 PiB

EXPERIMENTAL

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

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

Interventions

F-18 AV 1451DRUG

Tau binding agent

PiB PET Scan, C-11 PiBTau PET Scan, F-18 AV 1451
C-11 PiBDRUG

Amyloid binding agent

PiB PET Scan, C-11 PiBTau PET Scan, F-18 AV 1451

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jennifer Whitwell, Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 15, 2016

Study Start

May 1, 2016

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)