Safety and Efficacy of Positron Emission Tomography Imaging With MNI-513

NCT01000870 | Terminated Early Phase 1

• 1 other identifier: MNI-513-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Access MNI-513 and PET Imaging

EXPERIMENTAL

Drug: MNI-513-01

Interventions

MNI-513-01 DRUG

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.

Access MNI-513 and PET Imaging

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• has at least 6 years of education
• 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
• 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
• 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
• informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)
• 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, \[Folstein et al. 1975\])
• 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)
• 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)

You may not qualify if:

• 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)
• has a CDR \[Hughes et al. 1993\] score of 0.5, 1 or 2
• 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)
• has a caregiver who is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
• has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan
• is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
• is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
• is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable, e.g. patients / volunteers within 14 days of myocardial infarction or stroke, unstable patients / volunteers with previous surgery (within 7 days), patients with advanced heart insufficiency (NYHA stage IV), or with acute renal failure
• has a history of exposure to any radiation \>15 mSv/year (e.g. occupational or radiation therapy)
• is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
• has received anti-amyloid drug therapy.
• has received any contrast material (X-ray, MRI) or radiopharmaceuticals within 48 hours prior to the application of the IMP or for whom application of such a substance is planned for the 24 hours following IMP administration
• has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical within 10 radioactive half-lives prior to IMP administration
• has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
• has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeld-Jacob disease

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Danna Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 6, 2010

Record last verified: 2010-10

Locations

US (1)