Longitudinal Changes of [18F]PI-2620 Positron Emission Tomography in Subjects With Cognitively Normal, Mild Cognitive Impairment and Alzheimer's Disease

Jae Seung Kim

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Cognitively Normal

Treatments: Drug: [18F]PI-2620

Study type: Interventional

Funder types: Other

Identifiers

NCT03903211

PI-18002

Details and patient eligibility

About

The overall goal of this imaging trial is to evaluate crosssectional difference and longitudinal changes of [18F]PI-2620, a tau targeted positron emission computed tomography radioligand, in cognitively normal individuals, and subjects with mild cognitive impairment and Alzheimer's disease.

Enrollment: 84 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. General Subject Inclusion Criteria

   In order to be eligible for participation in this trial, the subject must:

   • Be ≥ 40 and < 85 years of age at the Screening Visit.
   • Be able to read at a 6th grade level or equivalent, (as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.)
   • Be able to speak, read, hear, and understand the language of the trial staff, and the informed consent form, and possess the ability to respond verbally to questions, follow instructions, and complete questionnaires and detailed neuropsychological test.
   • Have results of clinical laboratory tests/physical examination, vital signs, and ECG within normal limits (at 90 days prior to [18F]PI-2620 positron emission computed tomography) or clinically acceptable to the investigator at screening.
   • If female, not be of childbearing potential as indicated by one of the following
   • Each subject (or legal representative) must sign the informed consent form in accordance with local requirements after the scope and nature of the investigation have been explained to them, and before screening assessments.

2. Cognitively normal individuals

3. Subjects with Mild Cognitive Impairment

4. Subjects with Alzheimer Disease

Exclusion criteria

The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:

1. General Exclusion Criteria

   • Based on the investigators' judgement, if the patient is not capable of communicating with the site personnel, if the patient is not proficient in the language in which the psychometric tests will be completed, or if the patient is not sufficient for compliance with the study procedures.
   • The patient has an abnormal physical examination or abnormal laboratory test results at the screening that are clinically significant to affect results of the research, as judged by the investigator.
   • If the patient has or is suspicious of having a hypersensitivity or allergy to [18F] PI-2620 or its derivatives.
   • The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) children.
   • The patient has a history of alcoholism or drug dependency/abuse within the last 2 years before screening.
   • The patient has contraindications to undergo positron emission computed tomography or MRI, which include but are not restricted to the examples below: claustrophobia, cardiac pacemaker, metal devices around the eye or spinal cord, cochlear implant, etc.) at the screening visit.
   • The patient has been treated with any investigational medicinal product (IMP) within 1 years prior to the screening visit.

2. Cognitively normal individuals

3. Subjects with Mild Cognitive Impairment

4. Subjects with Alzheimer Disease

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 3 patient groups

Cognitively normal individuals

Experimental group

Description:

Cognitively normal individualswill receive a single IV injection of \[18F\]PI-2620.

Treatment:

Drug: [18F]PI-2620

Subjects with Mild Cognitive Impairment

Experimental group

Description:

Subjects with Mild Cognitive Impairment will receive a single IV injection of \[18F\]PI-2620.

Treatment:

Drug: [18F]PI-2620

Subjects with Alzheimer Disease

Experimental group

Description:

Alzheimer Disease Subjects with Alzheimer Disease will receive a single IV injection of \[18F\]PI-2620.

Treatment:

Drug: [18F]PI-2620