Imaging Tau Deposition in the Brain of Elderly Subjects (Add-Tau)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02958670|
Recruitment Status : Enrolling by invitation
First Posted : November 8, 2016
Last Update Posted : October 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Healthy Alzheimer Disease Neurocognitive Disorders||Other: 18F-AV-1451 (Tau-PET tracer)||Not Applicable|
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:
- We assume that it is possible to identify tau deposition in subjects with and without cerebral Abeta deposition.
- 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)|
|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|
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
- Volume of Interest (VOI) or Voxel based assessment of 18F-AV-1451-PET-signal [ Time Frame: Baseline measurement ]
- 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 ]
- Neuropsycholgical test performance [ Time Frame: up to two years ]
- Magnetresonance Tomography (MR) readouts [ Time Frame: Baseline and two years ]
- Blood and CSF-biomarker-read outs [ Time Frame: Baseline and two years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958670
|Institute for Regenerative Medicine (IREM)|
|Schlieren, Zurich, Switzerland, 8952|
|Principal Investigator:||Christoph Hock, Prof.Dr. med||Director Institute for Regenerative Medicine, University of Zurich|