Biodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects.(Positron Emission Tomograph )

Chang Gung Medical Foundation

Status and phase

Completed

Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: F-18 THK-5351

Study type

Interventional

Funder types

Other

Identifiers

NCT02686216

104-2710A

Details and patient eligibility

About

Biodistribution, pharmacokinetics, and safety of F-18 THK-5351 PET in Alzheimer's disease patients and healthy subjects.

Full description

Totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12 probably Alzheimer's dementia patients with NINCDS-ADRDA criteria. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.

Enrollment

24 patients

Sex

All

Ages

20 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy Inclusion Criteria:

Neurologic testing. (MMSE 24-30, Wechsler Logical Memory score >5).
Subjects must provide written inform consent.

Patients with AD Inclusion Criteria:

Diagnosis of AD according to the clinical diagnostic criteria of "possible AD" with NINCDS-ADRDA criteria
MMSE 20-26, Clinical dementia rating 0.5 or 1, Wechsler Logical Memory score<=4
Patient who provide a written informed consent prior to study entry. (If the patient is incapable informed consent, the caregiver may consent on behalf of the patient. The caregiver should be able to report activities of daily living and their mental status.)

Exclusion Criteria:

Pregnant or become pregnant
Current breast feeding
Clinically significant abnormal laboratory values
Unstable medical or psychiatric illness.
Cardiovascular disease (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease).
History of drug or alcohol abuse within the last year, or prior prolonged history of abuse. --History of severe allergic or anaphylactic reactions particularly to the tested drugs .
PI assessment with high risk.