Measuring the amount of tau binding

Phase 1

• Conditions: Alzheimer's Disease (AD); MedDRA version: 18.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 18.1 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 18.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2015-004230-10-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

A healthy control subject must meet all of the following criteria:
1. At least 50 years of age;
2. Have no evidence of cognitive impairment as indicated by a cognitive neurologist;
3. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV1451 PET scan procedures.

Probable AD subjects must meet the following inclusion criteria:
1. At least 50 years of age;
2. Have a clinical diagnosis of probable AD (McKhann, 2011) and are part of the Amsterdam Dementia Cohort (Flier et al. 2014);
3. Have a Mini Mental State Examination (MMSE) of 18 or higher;
4. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV-1451 PET scan and blood sampling procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study if he or she:

1. Has contra indications for MRI scanning and therefore can not receive brain MRI
2. Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of a PET scan;
3. Has a history of severe traumatic brain injury (TBI);
4. Has a hemoglobin test (Hb) result of < 8 in males and < 7 in females;
5. Is a female of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant or breastfeeding at screening.
6. Has a relevant history of severe drug allergy or hypersensitivity (relevant severe drug allergies should be determined by the Principal Investigator or Co-Principal Investigator, and any questions about a subject’s eligibility can be directed to Avid Radiopharmaceuticals Inc.);
7. Has current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (including but not limited to QTc>450 msec). If QTc is >450 at screening, the principal investigator may consult with Avid for approval to enroll;
8. Has a history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT syndrome) or is taking drugs that are known to cause QT-prolongation;
9. Has donated blood within 6 months prior to the [18F]AV-1451 PET scan day;
10. Has ever participated in an experimental study with a tau or amyloid targeting agent, unless it can be documented that the subject received only placebo during the course of the trial.
11. Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To validate the previously defined simplified tracer kinetic model to quantify specific binding of [18F]AV-1451;Secondary Objective: To assess test-retest variability of quantitative [18F]AV-1451 outcome measures;Primary end point(s): Test-retest variability of [18F]AV-1451 binding;Timepoint(s) of evaluation of this end point: Continuous PET scan from 0-60 and 80-130 minutes post injection and continuous arterial blood draw 0-60 minutes post injection. Repeat after 1 week.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: At baseline and after 1 week follow up