Alzheimer Disease
Conditions
Keywords
Alzheimer
Brief summary
This is a phase 2, open-label, multiple-center, non-randomized single dose study to assess the safety and efficacy of \[18F\]NAV4694 PET imaging in detecting beta-amyloid plaque in the brain in subjects with probable AD compared with healthy volunteers.
Interventions
DRUG[18F]NAV4694
Sponsors
Navidea Biopharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
All participants: * is able to provide informed consent or assent, and exhibits adequate visual, auditory, and communication capabilities to enable compliance with study procedures * should be able to perform the psychometric testing * has a modified Hachinski score ((Hachinski, et al., 2012; Rosen, et al., 1980) ≤ 4 at screening * possesses a general health that permits adequate compliance with all study procedures as ascertained by a detailed review of the medical history, surgical history, laboratory and physical examination findings, which must be performed within 56 days prior to administration of \[18F\]NAV4694 * informed consent has been signed and dated by the subject and/or the subject's legally authorized representative (LAR; for probable AD subjects) Healthy Volunteers Only * is male or female and is between the age of 18 and 40 years (for younger HVs) or 55 to 85 years of age (for older HVs) * if female does not have childbearing potential: must be confirmed by either: post-menopausal status; or history of surgical sterilization or of hysterectomy * if female has childbearing potential: must demonstrate a negative serum beta-HCG level at screening and a negative urine pregnancy test on the day of injection (prior to injection) consistent with a non-gravid state and agree to use two acceptable forms of birth control * has no evidence of cognitive impairment as indicated by a clinical dementia rating (CDR) (Morris, 1993) score of 0 (zero) and a score of ≥ 28 in the Mini-Mental State Examination (MMSE) (Folstein, et al., 1975) * has MRI brain scan that has been judged as normal (age-appropriate) supporting the lack of cerebrovascular disease (e.g., a white matter lesion score of 0, 1, or 2 and a basal ganglia score of 0 to 1 on the ARWMC scale) Probable Alzheimer's Disease Subjects Only * is male or female and is ≥ 55 of age, whereby females must be without childbearing potential (confirmed by either:post-menopausal status; or history of surgical sterilization or of hysterectomy) * presents with positive assessment for dementia of Alzheimer's type in accordance with the DSM-IV-TR and probable AD according to the NINCDS-ADRDA criteria and fulfills none of the
Exclusion criteria
of either * does not fulfill the International Consensus Criteria (ICC) for probable diffuse Lewy body disease (DLBD), the NINDS-AIREN for probable vascular dementia, or the Neary criteria for frontotemporal dementia (FTD) \[Neary et al. 1998\] * has a MMSE score between 16 and 23 * has a CDR (Morris, 1993) score of 1 to 2 * has a Cornell Scale for Depression in Dementia (CSDD; (Alexopoulos, et al., 1988)) score less than or equal to 18 (definite major depression) * MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease changes (limited to: a white matter lesion score of 0, 1, or 2 and a basal ganglia score of 0 or 1 on the ARWMC scale) * has a caregiver who is willing and able to attend study visits and perform the psychometric tests requiring the presence of a caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [18F]NAV4694 PET visual assessment by centralized readers | 25 minutes post injection | To evaluate \[18F\]NAV4694 PET visual assessment by centralized readers for detection of cerebral beta-amyloid plaque in subjects diagnosed with probable Alzheimer's disease compared with similarly aged and young healthy volunteers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the incidence of adverse events after a single dose of [18F]NAV4694 | 7 Days | To assess the incidence of adverse events after a single dose of \[18F\]NAV4694 PET in individuals diagnosed with probable AD and similarly aged and young healthy volunteers. |
| Evaluate [18F]NAV4694 PET quantitative assessment | 25 minutes post injection | To evaluate \[18F\]NAV4694 PET quantitative assessment, by assessing standard uptake value ratios (SUVR) for detection of cerebral beta-amyloid plaque in subjects diagnosed with probable Alzheimer's disease compared with similarly aged and young healthy volunteers. |
| Determine correlation of neuro-psychiatric tests with [18F]NAV4694 imaging | 25 minutes post injection | To determine the correlation of neuro-psychiatric tests with the beta-amyloid plaque burden determined by correlating various baseline neuro-psychiatric test scores with the \[18F\]NAV4694 PET imaging results in subjects diagnosed with probable AD |
| Assess changes in laboratory values after a single dose of [18F]NAV4694 | 7 days | To assess changes in laboratory values after a single dose of \[18F\]NAV4694 PET in individuals diagnosed with probable AD and similarly aged and young healthy volunteers. |
Countries
United States
Outcome results
None listed