Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease

Douglas Scharre

Status: Enrolling

Conditions: Alzheimer's Disease; Lewy Body Dementia; Parkinson's Disease

Treatments: Radiation: F18-AV-45; Genetic: APOE genotype; Radiation: DaTscan; Behavioral: Clinical Assessment; Radiation: FDG-PET; Procedure: Polysomnogram

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03019757

2014H0415

Details and patient eligibility

About

The study is designed to characterize the clinical, neuropsychological, polysomnographic, and neuroimaging findings among subjects with Alzheimer's disease, Lewy Body dementia, and Parkinsons' Disease.

Full description

The study will use structural and functional MRIs, daTscans, fluorodeoxyglucose (FDG) PET scans, Amyvid PET scans, polysomnographs, neuropsychological testing, cerebrospinal fluid in willing participants to distinguish between a diagnosis of Alzheimer's disease, Lewy Body dementia, and Parkinson's Disease. All subjects will have a clinical evaluation, physical examination including vital signs and orthostatic blood pressures and pulses, neurological examination including UPDRS evaluation, genetic blood sample collection, neuropsychological testing, polysomnogram, and neuroimaging. The study partner will also be interviewed for completion of all of the behavioral and functional measures.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must meet the standard clinical criteria of the syndromes of interest
• All subjects must have enough cognitive abilities to complete study procedures, which will be operationally defined as having a Mini Mental State Examination (MMSE) score greater or equal to 10.
• Subjects must be on stable cognitive and psychoactive medication regimen for the preceding four weeks of enrollment.
• Subjects must have a responsible study partner that either lives with them or is in regular contact with them at least 4 out of 7 days per week.
• Subjects must have visual and auditory acuity adequate for testing.

Exclusion criteria

• Any other condition (other than the primary diagnosis), which in the opinion of the investigators might contribute to the syndrome of dementia or complicate its assessment.
• active medical disorder that could preclude participation in this protocol
• Women who are pregnant or are breast feeding
• severe renal impairment as defined by glomerular filtration rate (GFR) less than 30 (may have increased radiation exposure with the DaTscan).
• Subjects in whom English is not the 1st language
• Subjects with educational level less than 12 years
• Subjects who have ever participated in an experimental study with an amyloid targeting agent unless it can be documented that the subject received only placebo during the course of the trial.

Trial design

76 participants in 3 patient groups

Alzheimer's disease

Description:

Individuals with a clinical diagnosis of Alzheimer's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment.

Treatment:

Procedure: Polysomnogram

Radiation: FDG-PET

Behavioral: Clinical Assessment

Radiation: DaTscan

Genetic: APOE genotype

Radiation: F18-AV-45

Lewy Body dementia

Description:

Individuals with a clinical diagnosis of Lewy Body Dementia will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment.

Treatment:

Procedure: Polysomnogram

Radiation: FDG-PET

Behavioral: Clinical Assessment

Radiation: DaTscan

Genetic: APOE genotype

Radiation: F18-AV-45

Parkinson's disease

Description:

Individuals with a clinical diagnosis of Parkinson's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment.

Treatment:

Procedure: Polysomnogram

Radiation: FDG-PET

Behavioral: Clinical Assessment

Radiation: DaTscan

Genetic: APOE genotype

Radiation: F18-AV-45