Early Detection of Mild Cognitive Impairment in Individual Patients

NCT00243451 | Completed

• 1 other identifier: LSUHSC H04-049
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Our central hypothesis is that the early metabolic lesions of MCI can be reliably detected in individual subjects by objective analysis of \[18\]F-fluorodeoxyglucose (FDG) positron-emission tomography (PET) brain images, earlier and more accurately than by subjective clinician rating.

Conditions

Mild Cognitive Impairment; Mild Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Determine if the Cognitive Decline Index will discriminate subtle lesions earlier than the standard analysis of the Nuclear Medicine physician.

  within the next 3 years

Secondary Outcomes (1)

• Determine if sensitivity, specificity, receiver-operator characteristics, and predictive value of our method are appropriate for translation into a clinically useful tool.

  within the next three years

Interventions

PET scan & fMRI OTHER

Subjects will be screened and if applicable for the study will be scheduled for an MRI. At the third visit they will complete the PET scan. They will return at 6, 12, 24, and 36 months and complete another PET scan at the last visit.

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects must have a diagnosis of MCI or mild AD.

You may qualify if:

• MCI criteria met:
• Memory complaint, preferably corroborated by an informant.
• Objective memory impairment (based on cognitive test scores).
• Normal general cognitive function.
• Intact ADL.
• Not demented.
• At least 10 years of education, or GED, or equivalent.
• Patients with ApoE4 positive homozygous or heterozygous status and/or first-degree relative with probable AD are preferred, but patients who meet all other criteria including well-defined MCI criteria will be accepted.
• Age: 55-85
• Have normal or clinically unimportant physical exam, beyond those consistent with a diagnosis of MCI.
• Able to give informed consent, or assent and informed consent from a legal representative.
• Centrally acting medications will be closely tracked, patients on any such medications will be PET-scanned only after a 24-hour washout, with meds restarted immediately after the scan.
• Because depression and depressive pseudodementia are often prodromal to cognitive decline, these diagnoses will not be exclusive.
• MRI findings must be normal or unremarkable for the age of the patient. Examples of abnormal (exclusory) findings are occult lacunar infarct, arteriovenous malformation) Examples of non-exclusory findings include mild atrophy, mild to moderate periventricular white matter changes. Other MRI findings will be evaluated in consultation with coinvestigator neuroradiologists and clinical judgment will be used to determine if the subject can continue in the study.

You may not qualify if:

• Other neuropsychiatric diagnoses (e.g., stroke, head trauma, any psychotic disorder, Parkinson's) other than MCI.
• Major medical illness (e.g., diabetes, severe or uncontrolled hypertension), especially potential secondary causes of cognitive decline (e.g., hypothyroidism).
• Disease, combination of disease, or presentation that, in the clinician's judgment, could introduce intolerable variance into the PET brain scan image (example: coronary artery disease, hypercholesterolemia, on 5 medications, HTN 2 yrs controlled with meds, random glucose of 125, but no Dx of DM, Hx of ?TIA).
• Current substance or alcohol dependence or history of same, and no alcohol or substance abuse within the last eight weeks.
• You must have a Mini Mental State Examination score of greater than 20.
• You must have one or more of these signs and symptoms of mild AD:
• Cognitive impairment manifested as memory problems, problems with language, difficulty carrying out motor activities, difficulty naming things, and/or problems planning or organizing, all of which impair function and are worsening over time.
• You must have at least 10 years of education, or a GED, or its equivalent.
• We will be drawing blood to determine your ApoE genotype. ApoE4 is a risk factor for Alzheimer's disease. We will share these results with you, if you desire to know the results. ApoE4 is only a risk factor. That means it is possible to get Alzheimer's without being ApoE4 positive, and it is possible to be ApoE4 positive and not get Alzheimer's. If you are positive for the ApoE4 genetic marker, you can be included. If you do NOT have the ApoE4 genetic marker, then you must have all other criteria.
• Age: 55-85.
• Normal or clinically unimportant physical exam, beyond those consistent with a diagnosis of mild AD.
• Able to give informed consent, or assent and informed consent from a legal representative. You will be assessed for capacity and assent/consent obtained as appropriate based on the Consensus Recommendations for Research Consent for Cognitively Impaired Adults (2004, Alzheimer's Disease Association Disorder, 18 (3):171-175).
• If you take medications that have an effect on the brain, they will be closely monitored. You will be PET-scanned only after a 24-hour washout of this medication(s), but this medication(s) will be restarted immediately after the scan.
• Any problems related to the brain or mental disorders (e.g., stroke, head trauma, any psychotic disorder, Parkinson's) other than mild AD. Some mood disorders will be acceptable because depression is often a precursor to mild AD.
• Any major medical illness (e.g., diabetes, severe or uncontrolled hypertension), especially potential secondary causes of cognitive decline (e.g., hypothyroidism).

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

Study Sites (1)

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• James Patterson, MD PhD

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: October 24, 2005
• Study Start: September 1, 2003
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

US (1)