Alzheimer's Disease Trial, Not Yet Recruiting NCT05987007 Sponsor: New York State Psychiatric Institute Condition: Alzheimer's Disease
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Alzheimer's Disease Trial, Not Yet Recruiting

NCT05987007
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Participants must be English-speaking and between 60 and 85 years old.
  • Participants must score 22 or higher on a telephone-based memory and thinking test (T-MMSE) at the screening stage; if this score drops below 18 during the study, participation would be stopped.
  • Participants must show signs of a mild memory condition called amnestic Mild Cognitive Impairment (aMCI), as measured by two specific memory assessments (confirm with trial site for details).
  • Having memory complaints on their own is not automatically disqualifying — it only matters if it is also supported by objective test results.
  • Participants who take sleep medications more than 3 times per week would not be eligible, but those who take them 3 or fewer times per week may be asked to stop the medications before the study begins, with a doctor's guidance.
  • Participants must show signs of sleep difficulties, scoring 8 or higher on an insomnia questionnaire (Insomnia Severity Index) taken without sleep medications.
  • Participants must be able to understand and agree to take part in the study on their own (capacity to provide informed consent).
  • Participants must have access to a reliable internet connection.
  • Participants must have a family member or another person who knows them well and is willing to provide information about them during the study — this person can participate by phone if they do not live with the participant.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have had a stroke or have a high risk of cardiovascular (heart and blood vessel) disease.
  • People with a neurological condition such as movement disorders, multiple sclerosis (MS), epilepsy, or a traumatic brain injury that caused loss of consciousness for more than 15 minutes.
  • People with untreated diabetes.
  • People currently undergoing treatment for cancer.
  • People who score below 22 on the telephone memory test, or who score above certain thresholds on a memory recall test based on their level of education (confirm specific score thresholds with trial site).
  • People with sleep disorders other than insomnia — such as moderate to severe sleep apnea, REM sleep behaviour disorder, restless legs syndrome, or circadian rhythm disorders. Mild sleep apnea is not disqualifying.
  • People with a current diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or a substance or alcohol use disorder.
  • People taking certain antidepressants known to have strong anticholinergic effects, including amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, isocarboxazid, lithium, maprotiline, mirtazapine, nortriptyline, tranylcypromine, trimipramine, and phenelzine. Other medications are generally permitted.
  • People taking medications in the benzodiazepine family, including diazepam, quazepam, estazolam, alprazolam, clorazepate, oxazepam, chlordiazepoxide, lorazepam, flurazepam, triazolam, temazepam, and midazolam.
  • People with moderate to severe depression, as measured by a score above 8 on the Geriatric Depression Scale; those with moderate depression (score of 5–8) may be encouraged to return for screening after receiving treatment and showing improvement.
  • People who are unable to provide a contact person (informant) to participate alongside them in the study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Hyun Kim, PhD, Columbia University/ New York State Psychiatric Institute

Phone: 646-774-8459

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
New York State Psychiatric Institute
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

No Practice Effect (NPE) battery; Everyday Cognition (ECog); Conners Continuous Performance Test (CPT-3)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov