Last updated: March 27, 2024
Sponsor: Jeremy Koppel
Overall Status: Active - Recruiting
Phase
N/A
Condition
Psychosis
Mood Disorders
Tourette's Syndrome
Treatment
Tau PET imaging scan
Clinical Study ID
NCT06336382
23-0874
1R21MH135148
Ages 65-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, aged 65-85 years.
- Diagnosis of late-onset non-affective primary psychotic disorder consistent witheither very late-onset schizophrenia-like psychosis (VLOSP, International Late-OnsetSchizophrenia Group consensus criteria, Howard et al., 2000) or delusional disorder (DSM-5 criteria)
- Caregiver available to provide collateral history and participation in informant-basedratings (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 byscoring within 1.5 SD range in education adjusted norms of the Logical Memory IIsubscale
- Ability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation (hearingaids permitted).
Exclusion
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 minutesof loss of consciousness; a movement disorder including Parkinson's disease; stroke;autoimmune disease affecting the CNS; substance abuse disorder; or activedelirium/encephalopathy.
- Evidence of a clinically relevant neurological disorder
- Modified Hachinski ischemia score of more than 4.
- History of alcoholism or drug dependency/abuse within the last 5 years beforescreening.
- Presence of metal implants such as pacemakers, ear implants, internal bullet fragmentsor shrapnel.
- Inability to lie flat for 1 hour approximately.
- Hearing impairment as evidenced by the inability to hear 500, 1000 and 1500 Hzbilaterally on a hearing evaluation. Subjects with hearing aids will be allowed toparticipate if they meet minimum hearing requirements.
Study Design
Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Tau PET imaging scan
Phase:
Study Start date:
February 16, 2024
Estimated Completion Date:
June 30, 2027
Study Description
Connect with a study center
The Feinstein Institutes for Medical Research
Manhasset, New York 11030
United StatesActive - Recruiting
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