Subjects with amnestic Mild Cognitive Impairment (aMCI) MedDRA version: 14.1 Level: HLGT Classification code 10057167 Term: Mental impairment disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Flutemetamol (18F) Injection
Product Code: AH110690 (18F) Injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F] flutemetamol, radioactive
CAS Number: 765922-62
Sponsors
GE Healthcare Ltd and its affiliates
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The subject has at least a sixth grade education or has a good work history (sufficient to exclude mental retardation). (2) The subject’s general health is adequate to comply with study procedures, as ascertained by review of their screening medical history and physical examination. (3) For women who are either surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or are postmenopausal (cessation of menses for more than 2 years), enrollment in the study without a pregnancy test at screening will be allowed. For women of childbearing potential, the results of a serum and urine human chorionic gonadotropin pregnancy test (with the result known on the day of and before tracer administration) must be negative. (4) The subject and/or the subject’s legally acceptable representative, if applicable, in accordance with local regulations, has signed and dated an informed consent. (5) The subject is 55 years old or older. (6) The subject meets the Petersen criteria for aMCI. (7) The subject has a score of = 4 on the Modified Hachinski Ischemic Scale. (8) The subject has a MMSE score of 24-30 (exceptions may be made for subjects with less than 8 years of education at the discretion of the Investigator). (9) The subject has adequate visual and auditory acuity to allow neuropsychological testing. (10) The subject has a non-contrast MRI examination as part of the screening visit or within the previous 6 months, that excludes aMCI arising from structural causes (e.g. vascular disease, hydrocephalus) and is of sufficient diagnostic quality (details provided in Imaging Manual) for VOI definition. (11) The subject is willing and able to participate in the trial. (12) The subject has a Hamilton Depression Scale Score of = 12 on the HAM-D 17. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: (1) The subject has participated in any other clinical study utilizing an investigational agent within 30 days of study entry. (2) The subject is pregnant or lactating. (3) The subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records. (4) The subject has any significant neurologic disease other than suspected aMCI; such as Parkinson’s disease, Huntington’s disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities. (5) The subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments, or pacemakers that would pose a risk during an MRI. (6) The subject has major depression, bipolar disorder, as described in the DSM-IV within the past 1 year. (7) The subject has history of schizophrenia (DSM-IV criteria). (8) The subject has had, within the prior 3 months, psychotic features, agitation, or behavioral problems that could lead to protocol compliance issues. (9) The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients. (10) The subject has clinically significant abnormalities in serum B12, folate, or thyroid functions that might interfere with the study. High concentrations of B12 and folate will be acceptable when due to treatment. (11) The subject regularly took medication with known anticholinergic effects (which could impair memory) within the last 3 months or in the view of the Investigator the subject is taking a drug that could impair cognition. a. Patients on psychoactive medications e.g., certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics are excluded. Note: subjects may take stable doses of antidepressants lacking anticholinergic side effects, if they are not currently depressed and have not had a history of a major depressive episode within the past 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the mean intra-subject test-retest variability in the cortical brain uptake (Standard Uptake Value Ratio (SUVR)) of [18F]flutemetamol based on a 30-minute time frame in subjects with amnestic Mild Cognitive Impairment (aMCI).;Secondary Objective: (1) To evaluate the mean intra-subject test-retest variability in the cortical brain uptake (SUVR) of [18F]flutemetamol in aMCI subgroups with normal and raised tracer uptake. (2) To evaluate the intra-subject test-retest variability in the cortical brain uptake (SUVR) of [18F]flutemetamol as a function of the amount of uptake. (3) To investigate the test-retest comparison with shorter time frames (5, 10, and 20 min). (4) To determine the extent of agreement of the separate blinded visual assessments of a subject’s test and retest images as normal or abnormal. (5) To assess the safety of repeat administrations of Flutemetamol (18F) Injection. ;Primary end point(s): The primary efficacy endpoint will be the brain uptake of [18F]flutemetamol (Standard Uptake Value Ratio (SUVR)) measured by Volume of Interest (VOI) analysis on a 30-minute scanning time. The primary safety endpoints Vital signs, laboratory assessments, electrocardiogram, physical/neurological examination, and AEs will be monitored and evaluated. ;Timepoint(s) of evaluation of this end point: PET imaging will be conducted for 30 minutes starting approximately 90 minutes after dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint will be the brain uptake of [18F]flutemetamol (SUVR) measured by VOI analysis based on 5-, 10-, and 20-minute scanning times. Also a secondary endpoint will be the blinded visual assessment of each subject’s Flutemetamol F 18 Injection brain PET images as normal or abnormal. The assessment will be performed by 5 independent blinded readers trained in the evaluation of PET fibrillar amyloid ß imaging.;Timepoint(s) of evaluation of this end point: The secondary endpoint will be measured by VOI analysis based on 5-, 10-, and 20-minute scanning times. | — |
Countries
Sweden
Contacts
Public ContactRegulatory Affairs
GE Healthcare AB
Outcome results
None listed