Single Photon Emission Computed Tomography (SPECT) Imaging Study to Develop a Biomarker for Alzheimer's Disease

NCT00886951 | Terminated Phase 1

• 1 other identifier: MNI-388/390-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this proposal are as follows:

• To assess the dynamic uptake and washout of 123-I MNI-388 and MNI 390, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls
• To perform blood metabolite characterization of 123-I MNI-388 and MNI-390 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-388 and MNI 390 as a single photon computed tomography (SPECT) brain imaging agent

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• To determine the reliability of MNI 388/390 as a potential imaging biomarker for amyloid imaging in the brain

  2 years

Study Arms (1)

Access I123MNI388/I123MNI390 and brain imaging

EXPERIMENTAL

Drug: I123MNI388/I123MNI390

Interventions

I123MNI388/I123MNI390 DRUG

Subjects will be dosed by intravenous injection up to 5 mCi and not to exceed 5.5 (not \>10% of 5 mCi limit) 123-I MNI-388 or 123-I MNI-390.

Access I123MNI388/I123MNI390 and brain imaging

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is 50 years or older.
• Written informed consent is obtained.
• Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
• CDR score ≥0.5 and \<2.
• Modified Hachinski Ischemia Scale score of ≤ 4.
• For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-388 or 123-I MNI-390 injection.

You may not qualify if:

• Alzheimer's subjects will be excluded from participation for the following reasons:
• The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease.
• The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
• The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
• The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
• Clinically significant MRI evidence of vascular disease or alternative neurologic disorder
• Pregnancy
• Concomitant therapy: patients may remain on a stable dose of anticholinesterase medication during the study. Use of donepezil (Aricept®), rivastigmine (Exelon®), galantamine (Razadyne®), tacrine (Cognex®), and memantine (Namenda®) are permitted during the study. Doses of these compounds must be stable for 2 months prior to the study. At each visit after the screening visit, the investigator will ask the patient whether any medications including OTC medications, were taken since the previous visit.
• Use of antipsychotics for agitation and benzodiazepines for insomnia or anxiety is permitted. However, the use of these agents is not permitted within the 8 hours prior to administration of cognitive testing.
• The participant is 50 years or older.
• Written informed consent is obtained.
• Negative history of neurological or psychiatric illness based on evaluation by a research physician.
• CDR score 0.
• For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-388 or 123-I MNI-390 injection.
• Healthy control subjects will be excluded from participation for the following reasons:

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 L Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

US (1)