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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT02392468

NCT02392468
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

If you have schizophrenia:

  • You have a confirmed diagnosis of schizophrenia and have been in a stable, non-acute phase of your illness for at least 8 weeks before joining.
  • You have been on your current antipsychotic medication (a newer type, but not Clozapine) at the same dose for at least 8 weeks, OR on an older type of antipsychotic at the same dose for at least 6 months.
  • Any other psychiatric medications you take (apart from anti-seizure drugs and lithium) have been at a stable dose for at least 8 weeks; anti-seizure drugs and lithium are allowed if you have been on them for at least 6 months.
  • Your hallucinations and delusions are rated no more than moderate in severity (confirm with trial site).
  • Your disorganised thinking is rated no more than moderate in severity (confirm with trial site).
  • You have minimal movement side effects from medication and mild or moderate depressive symptoms at most (confirm with trial site).
  • You are between 18 and 55 years old.

If you have Alzheimer's disease:

  • You have a confirmed diagnosis of mild Alzheimer's dementia.
  • Your score on a standard memory and thinking test (MMSE) is between 18 and 26 out of 30.
  • You are between 55 and 85 years old (those over 85 may still be considered based on overall health, at the doctor's judgement).
  • You have either not taken common Alzheimer's medications (such as donepezil, galantamine, rivastigmine, or memantine) for at least 3 months, or you have been on a stable dose of these medications for at least 3 months.
  • You have a recent brain scan (CT or MRI) from within the past year, or you are willing to have one done at the screening visit.
  • A carer or support person may be present with you during study visits if needed.

If you are a healthy volunteer:

  • You are a male or female aged 18 to 85 years in good general health (those over 85 may be considered based on overall health, at the doctor's judgement).
  • Your age will be matched to other participants in the study as the trial progresses (confirm with trial site for current availability).

For everyone:

  • You are able and willing to follow all study procedures reliably.
  • You have signed and dated a consent form before your first visit; if you have a legal representative, they must also give written consent.

Who may not be able to join:

  • You have an active eye condition (such as cataracts, glaucoma, diabetic eye disease, or an eye infection) in one or both eyes.
  • You are planning to have eye treatment or eye surgery during the study.
  • You are currently using or plan to use steroid medications (as eye drops or taken by mouth/injection).
  • You are currently using or plan to use medications known to be harmful to the eye or optic nerve.
  • You are taking more than two antipsychotic medications.
  • Your Alzheimer's diagnosis is caused by another condition rather than Alzheimer's disease itself.
  • You have another neurological condition such as Parkinson's disease, epilepsy, multiple sclerosis, stroke, Huntington's disease, or vascular dementia.
  • You regularly need strong sleeping pills or anti-anxiety medications (such as diazepam).
  • If you have Alzheimer's disease, you have taken certain antidepressants (tricyclics or MAOIs), certain antipsychotics with strong anticholinergic effects, anticholinergic medications, St. John's Wort, carbamazepine, or Ginkgo extract within the past 3 months.
  • You have significant blood vessel disease in the brain linked to memory or thinking problems.
  • You have had serious thoughts of suicide in the past 3 months (confirm with trial site).
  • You have made a suicide attempt or taken steps toward one in the past 2 years.
  • You have an unstable or uncontrolled serious health condition affecting the gut, liver, kidneys, lungs, heart, immune system, blood, or hormones.
  • You are a woman who is pregnant, breastfeeding, or of childbearing age and not

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

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Boehringer Ingelheim
Registry
clinicaltrials_gov
Start date
15 April 2015
Est. completion
3 August 2017

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The Percentage of Participants With Adverse Events (AEs), Coded to the Medical Dictionary for Regulatory Activities - System Organ Class Eye Disorders, as Determined by the Investigator at the End of Trial

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov