Alzheimer Disease
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers.
Detailed description
To determine diagnostic efficacy of the MNI-513 PET scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the PET scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. PET scan findings will be classified either as abnormal (i.e., significant neocortical uptake in predefined regions) or as normal (i.e. no significant neocortical uptake in predefined regions). The nuclear physician will be unaware of the clinical diagnosis.
Interventions
DRUGMNI-513-01
Subjects will be administered a single IV injection of IMP with a total activity amounting to 300MBq (8.1 mCi) +/- 20% of MNI-513 followed by PET imaging.
Sponsors
Institute for Neurodegenerative Disorders
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
ALZHEIMER & HEALTHY VOLUNTEERS 1. is a man or woman and is ≥ 55 of age, whereby females must be without childbearing potential (confirmed by either: age ≥ 60; or history of surgical sterilization or of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start) 2. has at least 6 years of education 3. is able to provide informed consent or assent, and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. This includes performing the psychometric testing and being able to lie down flat in the PET scanner 4. possesses a general health that permits adequate compliance with all study procedures as ascertained by a detailed review of the medical history, laboratory and physical examination findings, which must be performed within 28 days prior to administration of IMP 5. the subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study in the opinion of the investigator 6. informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients) INCLUSION CRITERIA: HEALTHY VOLUNTEERS ONLY 1. has no evidence of cognitive impairment as indicated by a clinical dementia rating (CDR, \[Hughes et al. 1993\]) score of 0 (zero) and a score of ≥ 28 in the Mini-Mental Status Examination (MMSE, \[Folstein et al. 1975\]) 2. has in the CERAD neuropsychological test battery \[Welsh et al. 1994\] a z- score of ≥ (-1.00) for each subtest (except for the MMSE which is covered by criterion 1 above) 3. has MRI brain scan that has been judged as normal (age- appropriate) including ARWMC scale \[Wahlund et al. 2001\] scores supporting the lack of cerebrovascular disease (e.g., a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1) and a Scheltens scale \[Scheltens et al. 1992\] verifying the lack of cerebral atrophy (e.g. bilateral temporal lobe atrophy visual score of 0 or 1) INCLUSION CRITERIA: PROBABLE ALZHEIMER DISEASE ONLY 1. 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 fulfils none of the
Exclusion criteria
of either (see Appendix 1,2) 2. does not fulfill the ICC criteria for probable DLB (Appendix 3), the NINDS-AIREN for probable Vascular dementia (Appendix 5), or the Neary \[Neary et al. 1998\] criteria for FTD (Appendix 4) 3. has a CDR \[Hughes et al. 1993\] score of 0.5, 1 or 2 4. MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease (e.g., the ARWMC scale) changes limited to: a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1) 5. has a caregiver who is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers | 1 year |
Countries
United States
Outcome results
None listed