Clinical trial NCT00315250: Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease
Official title: Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Parkinsonian Syndrome
Keywords: Parkinson
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Molecular NeuroImaging
First posted: 2006-04-18
Enrollment: 225
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: We propose to build on preliminary data evaluating non-dopaminergic/non-motor clinical biomarkers to more fully assess these markers at the threshold of Parkinson disease (PD).

Development of reliable biomarkers for both dopaminergic and non-dopaminergic manifestations of Parkinson disease (PD) and related disorders may dramatically accelerate research on PD etiology, pathophysiology, and therapeutics. Biomarkers are broadly defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Specific biomarkers may be useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease progression.

Detailed description: Two hundred patients who have undergone neurological evaluation by their general community neurologist and have a questionable diagnosis of PD will be recruited to participate in this study. Subjects will be referred by the neurologists to the Institute for Neurodegenerative Disorders (IND) in New Haven, CT.

All subjects will be clinically evaluated at IND by a two movement disorders experts. At the baseline visit all subjects will also undergo \[123I\]ß-CIT SPECT ANAM, voice acoustics, olfactory, Spiral and biochemical testing. Each movement disorders expert will make an initial clinical diagnosis at baseline and again within three months follow-up. At the three month visit one movement disorder expert will be provided the DAT imaging data and will review that data with the subjects and referral physician. The other movement disorders physician will remain blind to the imaging and all other biomarker data. The blinded movement disorders expert will provide a final clinical diagnosis at the 12 month follow-up visit, which will represent the 'gold standard' diagnosis in this study. Statistical analysis to determine the sensitivity and specificity of ANAM, voice acoustics, olfactory, Spiral and biochemical testing compared to \[123I\]ß-CIT SPECT, and the gold standard clinical diagnosis will be completed. All subjects with DAT deficit and 10% of those without DAT deficit will be asked to return for repeat evaluation at 24 months.

Eligibility criteria: Inclusion Criteria:

* Older than 21
* Any parkinsonian symptoms
* Referral by community neurologist
* Parkinsonian symptoms for less than 2 years duration.
* Willingness to follow the study plan.

Exclusion Criteria:

* Pregnancy
* Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal electrocardiogram (ECG - tracing of the electrical activity of the heart)

Primary outcomes:
measure: Assess the sensitivity and specificity of olfaction, upper limb kinematic behavior, cognition, voice, metabolomic, proteomic and gene expression profiling in categorizing Parkinson Syndrome (PS) vs non-PS
timeFrame: 2 years
Secondary outcomes:
measure: Assess sensitivity and specificity of olfaction, upper limb kinematic behavior, cognition, voice, metabolomic, proteomic and gene expression profiling in categorizing PS vs non-PS
timeFrame: 2 years
measure: Correlate progression of biomarker outcomes for olfaction, upper limb kinematic behavior, cognition, voice, metabolomic and gene expression profiling with progression of PS defined by % change from baseline in putamen [123I]ß-CIT SPECT uptake.
timeFrame: 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: Danna Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References: