Imaging Tau Deposition in the Brain of Elderly Subjects

NCT02958670 | Active Not Recruiting

• 1 other identifier: KEK-ZH_Nr_2016-01079_V10.0
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Healthy; Alzheimer Disease; Neurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

• Volume of Interest (VOI) or Voxel based assessment of 18F-AV-1451-PET-signal

  Baseline measurement

Other Outcomes (4)

• 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

  up to two years

• Neuropsycholgical test performance

  up to two years

• Magnetresonance Tomography (MR) readouts

  Baseline and two years

Study Arms (1)

18F-AV-1451-PET

EXPERIMENTAL

All subjects receive a Scan for assessment of TAU with the radiotracer 18-F-AV-1451

Other: 18F-AV-1451 (Tau-PET tracer)

Interventions

18F-AV-1451 (Tau-PET tracer) OTHER

Single i.v. administration of 18F-AV-1451 (Tau-PET tracer) and consecutive Positron-Emission-Tomography-Scan

18F-AV-1451-PET

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject belongs to one of the following groups:
• No cognitive impairment
• Mild cognitive impairment according to Winblad et al., 2004
• Clinical diagnosis of dementia due to Alzheimer's disease compatible with DSM IV criteria or revised NINCDS-ADRDA criteria
• Evidence of neurodegenerative disease other than AD
• Written informed consent approved by the regulatory authorities
• Age ≥ 50 years, women must be without childbearing potential
• Pre-existing PET information (11C-Pittsburgh Compound B, 18F-Flutemetamol) on cerebral amyloid deposition
• German speaking or sufficient knowledge of German language to perform study assessments
• Subject is willing and able to name an informant who can give adequate information on the scales where informant input is required

You may not qualify if:

• Evidence for cognitive impairment mainly attributed to a non-neurodegenerative underlying medical condition (e.g. medication, brain tumor, severe heart insufficiency, hepatic encephalopathy)
• Evidence of larger cerebral infarcts, or lacunes in critical memory structures
• Disease or other condition with a potential to interfere with study participation
• Ongoing infection with human immunodeficiency virus (HIV) or any hepatitis virus
• Active, acute or chronic leukemia
• Severe illness likely to cause disability that interferes with study procedures in the following years
• 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
• Previous or current participation in anti-beta-amyloid or anti-tau therapeutic trials
• Contraindications against venous puncture
• Other condition that might pose a risk to the study subject in the opinion of the investigator

Sponsors & Collaborators

• University of Zurich: lead
• Avid Radiopharmaceuticals: collaborator
• Swiss Federal Institute of Technology: collaborator

Study Sites (1)

Institute for Regenerative Medicine (IREM)

Schlieren, Canton of Zurich, 8952, Switzerland

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Neurocognitive Disorders

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Cognition Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Christoph Hock, Prof.Dr. med

  Professor for Biological Psychiatry, Institute for Regenerative Medicine, University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 8, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)