Tau Biomarkers in Late-onset Psychosis (LOP) (NCT06336382) | Clinical Trial Compass
RecruitingNot Applicable
Tau Biomarkers in Late-onset Psychosis (LOP)
United States16 participantsStarted 2024-02-16
Plain-language summary
Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing.
Who can participate
Age range65 Years – 85 Years
SexALL
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Inclusion criteria
✓. Male or female, aged 65-85 years.
✓. Diagnosis of late-onset non-affective primary psychotic disorder consistent with either very late-onset schizophrenia-like psychosis (VLOSP, International Late-Onset Schizophrenia Group consensus criteria, Howard et al., 2000) or delusional disorder (DSM-5 criteria)
✓. Caregiver available to provide collateral history and participation in informant-based ratings (NPI,CDR)
✓. Clinical Dementia Rating (CDR) score of 0 or 0.5.
✓. Mini-Mental State Examination (MMSE) score ≥ 24 and at the screening visit.
✓. Normal memory function (to rule-out mild cognitive impairment, MCI) documented by scoring within 1.5 SD range in education adjusted norms of the Logical Memory II subscale
✓. Ability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation (hearing aids permitted).
Exclusion criteria
✕. Participants with affective and psychotic disorders including bipolar disorder, schizoaffective disorder, active major depression; insulin dependent type 2 diabetes; a history of CVD; a history of epilepsy; a history of TBI with greater than 15 minutes of loss of consciousness; a movement disorder including Parkinson's disease; stroke; autoimmune disease affecting the CNS; substance abuse disorder; or active delirium/encephalopathy.
✕. Evidence of a clinically relevant neurological disorder
✕. Modified Hachinski ischemia score of more than 4.
What they're measuring
1
Quantification of neurofibrillary tangle pathology in subjects via PET [18F]PI-2620 radiotracer uptake.
Timeframe: Each subject will have one PET imaging scan at visit 3 (week 4).
✕. History of alcoholism or drug dependency/abuse within the last 5 years before screening.
✕. Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel.
✕. Inability to lie flat for 1 hour approximately.
✕. Hearing impairment as evidenced by the inability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation. Subjects with hearing aids will be allowed to participate if they meet minimum hearing requirements.