NCT01503944

Brief Summary

The purpose of this study is to evaluate the ability to identify individuals with dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from Alzheimer's disease (AD) and control subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

July 14, 2010

Last Update Submit

August 3, 2012

Conditions

Dementia With Lewy BodiesAlzheimer's DiseaseParkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 18F-AV-133 striatal to occipital standard uptake value ratio

    The ratio of tracer activity in striatal target areas of interest relative to the occipital cortex reference region

    Four Weeks

Secondary Outcomes (1)

  • 18F-AV-45 cortical to cerebellar standard uptake value ratio

    Four Weeks

Study Arms (4)

Dementia with Lewy Bodies

OTHER
Drug: 18F-AV-133Drug: 18F-AV-45

Parkinson's disease

OTHER
Drug: 18F-AV-133Drug: 18F-AV-45

Healthy Elderly Volunteers

OTHER
Drug: 18F-AV-133Drug: 18F-AV-45

Alzheimer's Disease

OTHER
Drug: 18F-AV-133Drug: 18F-AV-45

Interventions

18F-AV-133DRUG

185 MBq

Alzheimer's DiseaseDementia with Lewy BodiesHealthy Elderly VolunteersParkinson's disease
18F-AV-45DRUG

185-370 MBq

Alzheimer's DiseaseDementia with Lewy BodiesHealthy Elderly VolunteersParkinson's disease

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female \> 50 years of age
  • Meet the diagnostic criteria for probable DLB as established by the DLB Consortium (McKeith et al., 2005)
  • Male or female \> 50 years of age
  • Meet the NINCDS criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
  • Male or female \> 50 years of age
  • Have probable PD according to the following criteria (Gelb et al., 1999):
  • Presence of 2 of the following 3 features: rest tremor, rigidity, bradykinesia;
  • Documented history of a sustained (\>6 months) improvement to Levodopa (L-DOPA) or a dopamine agonist
  • Absence of atypical clinical features or other possible signs or symptoms suggesting another cause of parkinsonism such as a history of frequent falls as a prominent early feature, localized brain lesion(s) or neuroleptic use
  • Asymmetric onset
  • A diagnosis of PD made within the 4 years prior to enrollment
  • Normal subjects:
  • Are males or females \> 50 years of age
  • Have a MMSE score \> 29, and are cognitively normal on the psychometric test battery at screening
  • Have no signs or symptoms of clinically meaningful parkinsonism

You may not qualify if:

  • Have a history or current diagnosis of other neurologic disease
  • Have evidence of clinically significant cerebrovascular disease
  • Have evidence from MRI or other biomarker studies that suggests the presence of a CNS pathology other than that associated with the study diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Sun City, Arizona, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Lewy Body DiseaseAlzheimer DiseaseParkinson Disease

Interventions

florbenazine F 18florbetapir

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersTauopathies

Study Officials

  • Chief Medical Officer

    Avid Radiopharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

January 4, 2012

Study Start

March 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

US(2)