Could hallucinations in seniors signal dementia? new study investigates
NCT ID NCT06336382
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looks at whether older adults who develop hallucinations or delusions for the first time may have early signs of dementia. Researchers will use special brain scans (tau PET) and blood tests to check for abnormal proteins linked to Alzheimer's. The goal is to better understand the connection between late-onset psychosis and cognitive decline.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors identify which older adults with new psychosis are at risk for dementia, enabling earlier monitoring or intervention.
- What could go wrong
- This is a very small, early study (16 people) that only observes and measures—it does not test any treatment. Results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Very late-onset schizophrenia-like psychosis (VLSOP) diagnostic criteria: VLSOP is a schizophrenia-like condition characterized by the onset of delusions (primarily persecutory but also bizarre delusions) and/or hallucinations (auditory, visual, tactile, or olfactory) after age 60 in the absence of negative symptoms, formal thought disorder, and affective flattening that are common in early-onset schizophrenia. Delusional disorder diagnostic criteria: Delusional disorder comprises the presences of non-bizarre delusions including erotomanic, grandiose, jealous, persecutory, or somatic subtypes. The presence of one (or more) above delusions with a duration of 1 month or longer.
- Ages
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65 to 85 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female, aged 65-85 years. 2. 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) 3. Caregiver available to provide collateral history and participation in informant-based ratings (NPI,CDR) 4. Clinical Dementia Rating (CDR) score of 0 or 0.5. 5. Mini-Mental State Examination (MMSE) score ≥ 24 and at the screening visit. 6. 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 7. Ability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation (hearing aids permitted). Exclusion Criteria: 1. 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. 2. Evidence of a clinically relevant neurological disorder 3. Modified Hachinski ischemia score of more than 4. 4. History of alcoholism or drug dependency/abuse within the last 5 years before screening. 5. Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel. 6. Inability to lie flat for 1 hour approximately. 7. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Feinstein Institutes for Medical Research
RECRUITINGManhasset, New York, 11030, United States