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Imaging Tau Deposition in the Brain of Elderly Subjects (Add-Tau)

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ClinicalTrials.gov Identifier: NCT02958670
Recruitment Status : Enrolling by invitation
First Posted : November 8, 2016
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
Avid Radiopharmaceuticals
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Cerebral accumulation of tau and beta-amyloid are major factors of Alzheimer's disease pathology. A novel Positron Emission Tomography (PET) tracer (18-F-AV-1451) now offers the ability to study tau protein deposition in vivo in subjects, in which information on cerebral amyloid deposition has already been gathered. This enables to study effects of tau deposition on neuronal integrity, their relation to effects of beta-amyloid deposition and how this contributes to cognitive impairment or well-being in the elderly.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Healthy Alzheimer Disease Neurocognitive Disorders Other: 18F-AV-1451 (Tau-PET tracer) Not Applicable

Detailed Description:

This is a single-center exploratory observational clinical study combining cross sectional and longitudinal aspects. It contains 18F-AV-1451-PET as an intervention. The primary objective is to measure tau deposition with 18-F-AV1451-PET based on voxel wise or volume based quantitative assessments and to study the effects of Tau deposition on the organism by identification of factors correlating to the measured tau deposition. Study participants will be followed for up to 5 years.

To date cerebral tau pathology in vivo was only estimated by cerebrospinal fluid (CSF) tau or CSF phospho-tau which precludes a study of topical distribution and interplay with Abeta pathology. 18F-AV-1451 offers the chance to visualize tau pathology and to study effects of tau on brain structure, brain physiology and cognitive function. Ideally, these effects are studied in well characterized individuals in whom other important pathological factors are already known.

We therefore plan to study tau pathology measured by 18F-AV-1451 in subjects with already existing data on cerebral amyloid deposition (11C-Pittsburgh Compound C, Flutemetamol). We will be able to relate tau pathology to past and prospective cognitive performance assessed by a detailed neuro¬psychological examination, and we will be able to investigate whether cerebral tau pathology is reflected by peripheral blood biomarkers. For this purpose we will include elderly subjects with various degrees of cognitive performance (cognitively healthy, mild cognitive impairment, dementia) and various degrees of cerebral amyloid deposition (dichotomized or quantitative). We will also include Frontotemporal Lobar Degeneration (FTLD) cases to study tau effects in neurodegenerative disease in the absence of beta-amyloid.

Our hypotheses are the following:

  1. We assume that it is possible to identify tau deposition in subjects with and without cerebral Abeta deposition.
  2. We hypothesize that tau-deposition will be associated with structural and physiological brain changes and that there are synergistic effects of the amount of tau and Abeta pathology on certain brain regions and on cognitive function.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Imaging Tau Deposition in the Brain of Elderly Subjects
Study Start Date : November 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-AV-1451-PET
All subjects receive a Scan for assessment of TAU with the radiotracer 18-F-AV-1451
Other: 18F-AV-1451 (Tau-PET tracer)
Single i.v. administration of 18F-AV-1451 (Tau-PET tracer) and consecutive Positron-Emission-Tomography-Scan




Primary Outcome Measures :
  1. Volume of Interest (VOI) or Voxel based assessment of 18F-AV-1451-PET-signal [ Time Frame: Baseline measurement ]

Other Outcome Measures:
  1. Transition from one clinical state to another (e.g. MCI to AD) worsening of clinical function measured as an increase in CDRSOB-score of one [ Time Frame: up to two years ]
  2. Neuropsycholgical test performance [ Time Frame: up to two years ]
  3. Magnetresonance Tomography (MR) readouts [ Time Frame: Baseline and two years ]
  4. Blood and CSF-biomarker-read outs [ Time Frame: Baseline and two years ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject belongs to one of the following groups:

    • No cognitive impairment (N=100)
    • Mild cognitive impairment according to Winblad et al., 20041 (N=50)
    • Clinical diagnosis of dementia due to Alzheimer's disease (N=30) compatible with DSM IV criteria or revised NINCDS-ADRDA criteria
    • Evidence of neurodegenerative disease other than AD (N=20)
  2. Written informed consent approved by the regulatory authorities
  3. Age ≥ 50 years, women must be without childbearing potential; male study subjects with fe¬male partners who are pregnant or of childbearing potential must agree to refrain from sexual activity for 24 hours following administration of 18F-AV-1451 injection. Male study subjects should not donate sperm for 24 hours following administration of 18F-AV-1451 injection.
  4. Pre-existing PET information (11C-Pittsburgh Compound B, 18F-Flutemetamol) on cerebral amyloid deposition
  5. German speaking or bilingual including German
  6. Subject is willing and able to name an informant who can give adequate information on the scales where informant input is required

Exclusion Criteria:

  1. Evidence for cognitive impairment mainly attributed to a non-neurodegenerative underlying medical condition (e.g. medication, brain tumor, severe heart insufficiency, hepatic encephalopathy)
  2. Evidence of larger cerebral infarcts, or lacunes in critical memory structures
  3. Disease or other condition with a potential to interfere with study participation
  4. Ongoing infection with human immunodeficiency virus (HIV) or any hepatitis virus
  5. Active, acute or chronic leukemia
  6. Severe illness likely to cause disability that interferes with study procedures in the following years
  7. Evidence of acute psychiatric disease (upon clinical decision) which may be a cause of cognitive impairment. Patients with a history of major depression under stable medication may be included. Patients with low dose intake of benzodiazepines may also be included upon clinician's decision
  8. Previous or current participation in anti-beta-amyloid or anti-tau therapeutic trials
  9. MR exclusion criteria
  10. PET exclusion criteria
  11. Contraindications against venous puncture
  12. Other condition that might pose a risk to the study subject in the opinion of the investigator
  13. Exclusion criteria for subproject CSF sampling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958670


Locations
Switzerland
Institute for Regenerative Medicine (IREM)
Schlieren, Zurich, Switzerland, 8952
Sponsors and Collaborators
University of Zurich
Avid Radiopharmaceuticals
Swiss Federal Institute of Technology
Investigators
Principal Investigator: Christoph Hock, Prof.Dr. med Director Institute for Regenerative Medicine, University of Zurich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02958670     History of Changes
Other Study ID Numbers: KEK-ZH_Nr_2016-01079_V5.0
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Neurocognitive Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Cognition Disorders