NCT00556764

Brief Summary

The main objectives of this protocol are as follows:

  1. 1.To assess the sensitivity and specificity of ANAM-PD in detecting cognitive status in patients with Parkinson disease (PD) and healthy controls (HC).
  2. 2.To validate the specific individual domains of the ANAM-PD cognitive battery by comparisons to available standardized cognitive evaluation scales administered to the patients with Parkinson disease with and healthy control subjects.
  3. 3.To evaluate the reliability of the ANAM-PD battery of tests by comparing repeated administrations of the ANAM-PD battery on a sub-set of subjects with Parkinson disease and healthy controls.
  4. 4.To characterize cholinergic neurotransmission through imaging the vesicular acetylcholine transporter binding with 123Iodobenzovesamicol (IBVM) and SPECT in PD patients and healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P75+ for early_phase_1 parkinson-disease

Timeline
Completed

Started Jul 2007

Typical duration for early_phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

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

July 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

3.7 years

First QC Date

November 8, 2007

Last Update Submit

February 8, 2012

Conditions

Parkinson Disease

Keywords

ANAMParkinson's

Outcome Measures

Primary Outcomes (1)

  • The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD

    6 mos

Study Arms (1)

2 cohorts

EXPERIMENTAL

In this observational study 2 cohorts will participate. Cohort 1 will include people with Parkinson disease and Cohort 2 will include healthy volunteers. A subset of twelve subjects (8 PD and 4 HC) will be enrolled in the \[123I\] IBVM and SPECT imaging portion of this study

Drug: [123I] IBVM and SPECT imagingDrug: Subjects will undergo the 123-I IBVM imaging visit

Interventions

[123I] IBVM and SPECT imagingDRUG

Subjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging.

Also known as: FUNCTIONAL BRAIN IMAGING
2 cohorts
Subjects will undergo the 123-I IBVM imaging visitDRUG

Subjects will be injected with a bolus of up to 4 mCi of 123-I IBVM followed by serial SPECT imaging.

Also known as: FUNCTIONAL BRAIN IMAGING
2 cohorts

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • PD subjects
  • The participant is 30 years or older.
  • Written informed consent is obtained.
  • Participants have a clinical diagnosis of Parkinson's disease based on Brain Bank Criteria.
  • Mini-mental status examination (MMSE) score ≥24 or significant cognitive dysfunction based clinical mental status exam.
  • Geriatric Depression Scales (GDS) ≤ 10.
  • For females, non-child bearing potential a negative urine or serum pregnancy test on day of 123-I IBVM injection.
  • 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).
  • Pregnancy
  • Healthy Control Subjects
  • 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.
  • Mini-Mental Status Exam score ≥28.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • Kabat MH, Kane RL, Jefferson AL, DiPino RK. Construct validity of selected Automated Neuropsychological Assessment Metrics (ANAM) battery measures. Clin Neuropsychol. 2001 Dec;15(4):498-507. doi: 10.1076/clin.15.4.498.1882.

    PMID: 11935451BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Iodine-123Functional Neuroimaging

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Danna L Jennings, MD

    Institute for Neurodegenerative Disorders

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 12, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

US(1)