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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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)

An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of Florbetapir (18F) in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

NCT01662882•Avid Radiopharmaceuticals

View on ClinicalTrials.gov

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).

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who meet all of the following criteria are eligible to enroll in the arm of this trial reserved for subjects with AD:
•1. Japanese males or females at least 50 years of age, with probable AD according to the NINCDS-ADRDA criteria (McKhann et al., 1984);
•2. Subjects with mild/moderate dementia as evidenced by a MMSE score ranging from 10 to 24, boundaries included, at screening;
•3. 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;
•4. Subjects who live with or have regular visits from a responsible caregiver willing to provide information about the subject's cognitive status; and
•5. 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:
•1. Japanese males or females at least 50 years of age;
•2. Subjects with complaint of memory or cognitive decline corroborated by an informant;
•3. Subjects with a Clinical Dementia Rating (CDR) of 0.5;
+14 more criteria

Exclusion Criteria

•Subjects with any of the following are ineligible to enroll in this trial:
•1. A documented diagnosis of MCI for greater than 1 year (for subjects considered for the MCI group);
•2. 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;
•3. 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.);
•4. Have had or currently have a diagnosis of mixed dementia;
•5. 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);
•* Hypoxic cerebral damage regardless of etiology; e.g. cognitive or neurological deficits resulting from cardiac arrest or cardiac surgery, anesthesia, or severe self-poisoning episode, secondary to severe hypovolemia (orthostatic hypotension should not lead to exclusion);
•* 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;
+34 more criteria

Locations (2)

Research Site

Kobe, Japan

Research Site

Tokyo, Japan

Key Dates

Start Date

October 1, 2012

Primary Completion Date

February 1, 2013

Completion Date

February 1, 2013

Last Updated

September 19, 2013

Enrollment

ACTUAL participants

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Interventions

florbetapir (18F)

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

View study

RECRUITINGPHASE1/PHASE2

Sense4Safety Intervention

NCT07220668

Mild Cognitive Impairment

View study

RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Sense4Safety Intervention

Lombard Cohort of Brain Health Services

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