IRB Study Number 17-044
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Neurological Institute
Description
The objective of the Dementia with Lewy Bodies Consortium (DLBC) is to utilize and expand the DLBC cohort with additional subjects enrolled, continued longitudinal systematic assessments, collection of biofluids and imaging data, and ultimately autopsy. The DLBC will utilize the longitudinal data, imaging and biofluid collection from DLBC participants to focus on diagnosis, progression, and clinical variability.
Inclusion Criteria
The subject sample will include individuals with either:
- Probable DLB, using 2017 McKeith Criteria
- “High likelihood” DLB individual with MCI: These participants will fulfill criteria for MCI and have at least one of the following characteristics: polysomnographic confirmed Rapid Eye Movement Behavior Disorder (RBD); recurrent formed visual hallucinations; abnormal dopamine transporter scan.
- Parkinson’s Disease Dementia
- PD-MCI: These participants will fulfill criteria for MCI in the context of established Parkinson's disease for at least 1 year (Level I criteria)
Males or females 40 to 90 years of age, inclusive, at the time of the baseline visit.
MoCA of 8 or above.
Have at least 8 years of education and should have previously been capable of reading, writing, and communicating effectively with others in English.
Consent or assent to protocol procedures at baseline. Lumbar puncture and autopsy if death occurs during the project timeline are required study procedures unless a waiver is submitted and approved by Dr. Leverenz or designated proxy.
Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend visits and report on subject's status. If the caregiver does not cohabitate with the subject, he/she ideally should have a minimum of 10 hours total and at least 3 days contact with the subject per week. Every effort should be made to have the same caregiver throughout the study.
Exclusion Criteria
Presence of structural neurological disease including significant stroke, evidence of head trauma, tumor, or other disorder.
Exclusionary criteria for any biofluid or imaging procedure linked to this study
Anticoagulant use required at the time of the LP, other than aspirin or non-steroidal anti-inflammatory medications.
Presence of devices, objects contraindicated for MRI (including but not restricted to non-removable ferrous metal objects, aneurysm clips, pacemakers, defibrillators)
Pregnancy at the time of the baseline DaTscan.
Unwillingness to attempt the cognitive and motor evaluations at baseline visit.
Any unstable medical condition at time of entry.
Consumption of a disease modifying investigational medication 6 weeks prior to baseline, or six half-lives of study medication (whichever is longer).
Currently enrolled in the placebo-controlled phase of an investigational drug trial. Participation in an open-label extension phase is allowable throughout the study for non-disease modifying medications (requires review and approval by DLBC PI, Dr. Leverenz).
