A Phase II Trial of Florbetapir (18F) Positron Emission Tomography (PET) Imaging in Japan of Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

NCT01662882 | Completed Phase 2 Results

• 2 other identifiers: 18F-AV-45-J05I6E-AV-AVBB
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluate florbetapir (18F) positron emission tomography (PET) imaging for distinguishing Japanese healthy control subjects, from Japanese subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Conditions

Alzheimer's Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Qualitative Amyloid Image Assessment

  Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.

  50-60 min after injection

• Mean Cortical to Cerebellum SUVR

  Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

  50-60 min after injection

Study Arms (3)

AD Subjects

EXPERIMENTAL

Drug: florbetapir (18F)

MCI

EXPERIMENTAL

MCI (mild cognitive impairment)

Drug: florbetapir (18F)

Healthy Controls

EXPERIMENTAL

Drug: florbetapir (18F)

Interventions

florbetapir (18F) DRUG

IV injection, 370 MBq(10mCi), single dose

Also known as: 18F-AV-45, Amyvid, Florbetapir F 18

AD Subjects; Healthy Controls; MCI

Eligibility Criteria

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

You may qualify if:

• Subjects who meet all of the following criteria are eligible to enroll in the arm of this trial reserved for subjects with AD:
• Japanese males or females at least 50 years of age, with probable AD according to the NINCDS-ADRDA criteria (McKhann et al., 1984);
• Subjects with mild/moderate dementia as evidenced by a MMSE score ranging from 10 to 24, boundaries included, at screening;
• Subjects whose history of cognitive decline has been gradual in onset and progressive over a period of at least 6 months. Evidence should be present indicating sustained memory deterioration in an otherwise cognitively normal subject, plus additional impairment in another cognitive function such as: orientation, judgment and problem solving, or functioning in personal care;
• Subjects who live with or have regular visits from a responsible caregiver willing to provide information about the subject's cognitive status; and
• Subjects who signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent prior to any study procedures. If the subject is incapable of giving informed consent, the caregiver may consent on behalf of the subject (the subject must still confirm assent).
• Subjects who meet all of the following criteria are eligible to enroll in the arm of this trial reserved for subjects with mild cognitive impairment:
• Japanese males or females at least 50 years of age;
• Subjects with complaint of memory or cognitive decline corroborated by an informant;
• Subjects with a Clinical Dementia Rating (CDR) of 0.5;
• Subjects with objective cognitive impairment or marginally normal cognition with a documented history of high cognitive performance;
• Have no obvious causes for their cognitive impairment (e.g., onset coincides with recent head trauma or stroke);
• Have sufficiently preserved general cognition and functional performance such that a diagnosis of AD cannot be made at the time of the screening visit;
• Subjects with essentially normal ADL;
• Subjects who are not demented;

You may not qualify if:

• Subjects with any of the following are ineligible to enroll in this trial:
• A documented diagnosis of MCI for greater than 1 year (for subjects considered for the MCI group);
• Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, frontotemporal dementia, Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy;
• Have had or currently have a diagnosis of other dementing / neurodegenerative disease (e.g. Parkinson's disease, dementia with Lewy bodies, Lewy body variant AD, etc.);
• Have had or currently have a diagnosis of mixed dementia;
• Cognitive impairment resulting from:
• Acute cerebral trauma or post-traumatic brain injury, subdural hematoma, or injuries secondary to chronic trauma (e.g. sequela from boxing);
• Vitamin deficiency states documented by medical history such as folate, vitamin B 12 and other B complex deficiencies; e.g. thiamin deficiency in Korsakoff's syndrome. (Note: subjects taking regular B12 and folate are not necessarily excluded);
• Cerebral infection including abscess, syphilis, meningitis, encephalitis or AIDS;
• Primary or metastatic cerebral neoplasia;
• Significant endocrine or metabolic disease; e.g., thyroid, parathyroid, or pituitary disease, Cushing's syndrome, or severe renal failure; or
• Mental retardation. Before enrolling a subject with past or current history of any of the above conditions, the investigator must contact the sponsor to discuss whether the condition could have contributed to the cognitive impairment.
• Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria, including:
• A history of a significant cerebrovascular event resulting in a physical or neurologic deficit that may confound the assessment of the subject's intellectual function;
• Multiple focal signs on neurologic examination indicative of multiple ischemic episodes;

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

Research Site

Kobe, Japan

Location

Research Site

Tokyo, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

florbetapir

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avid Radiopharmaceuticals, Inc.

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 13, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 19, 2013
• Results First Posted: September 19, 2013

Record last verified: 2013-07

Locations

JP (2)