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

NCT01662882

NCT01662882
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

If you have Alzheimer's disease (AD):

  • You are Japanese, male or female, and at least 50 years old, with a formal diagnosis of probable Alzheimer's disease
  • You have mild to moderate memory/thinking problems, based on a standard memory test score between 10 and 24
  • Your memory and thinking problems have been slowly and gradually getting worse over at least 6 months
  • You live with someone, or have someone who visits you regularly, who can give information about how your memory and thinking are doing
  • You are able to sign a consent form, or have a caregiver who can sign on your behalf (you would still need to show you agree)

If you have mild cognitive impairment (MCI):

  • You are Japanese, male or female, and at least 50 years old
  • You or someone close to you has noticed that your memory or thinking has declined
  • A doctor has rated your cognitive status at a level called "CDR 0.5," which indicates very mild impairment
  • You show some signs of memory or thinking difficulties, or your thinking is only borderline normal compared to what would be expected given your past abilities
  • Your memory or thinking problems do not have an obvious cause, such as a recent head injury or stroke
  • Your general thinking and daily functioning are still good enough that a full diagnosis of Alzheimer's disease cannot be made
  • Your ability to carry out everyday activities is mostly normal
  • You have not been diagnosed with dementia
  • Your score on a standard memory test is above 24
  • You are seeking a first diagnosis for memory or thinking concerns, or received your first diagnosis within the past year
  • You live with someone, or have someone who visits regularly, who can provide information about your thinking and memory
  • You are able to sign a consent form before any study procedures take place

If you are a cognitively normal volunteer:

  • You are Japanese, male or female, and at least 50 years old
  • Your score on a standard memory test is 29 or higher, and you show no signs of memory or thinking problems based on history and testing
  • You live with someone, or have a reliable person available, who can confirm your thinking and memory are normal
  • You are able to sign a consent form before any study procedures take place

Who may not be able to join:

  • You have had a diagnosis of mild cognitive impairment for more than 1 year (applies to the MCI group only)
  • You have a brain or nervous system condition other than Alzheimer's disease, such as Parkinson's disease, Huntington's disease, or similar conditions
  • You have been diagnosed with, or currently have, another type of dementia or brain-degenerating disease (such as Lewy body dementia)
  • You have been diagnosed with a mixed type of dementia
  • Your memory or thinking problems are caused by a brain injury, lack of oxygen to the brain, vitamin deficiencies, brain infection, brain tumour, significant hormone or metabolism problems, or intellectual disability (confirm with trial site)
  • You have had a significant stroke or have signs of multiple small strokes that may be affecting your thinking or shown on a brain scan
  • Your brain scan or other tests suggest your memory problems are caused by something other than Alzheimer's disease (or, for healthy volunteers, suggest early signs of Alzheimer's)
  • You currently have a significant mental health condition, such as major depression or schizophrenia, as defined by standard medical guidelines
  • You have a history of epilepsy or seizures, except for fever-related seizures in childhood
  • You have significant liver, kidney, lung, metabolism, or hormone-related health problems
  • You currently have significant heart or cardiovascular problems, such as a recent heart attack, unstable chest pain, uncontrolled high blood pressure, or serious heart rhythm problems (confirm with trial site for full details)
  • You have used drugs or alcohol heavily in the past year, or had a prolonged history of doing so
  • You have a significant infectious disease, including HIV/AIDS, or have previously tested positive for hepatitis
  • You are a woman of childbearing age who is pregnant, breastfeeding, or not using reliable contraception — and you must agree to avoid pregnancy for 24 hours after receiving the study imaging agent
  • In the opinion of the study doctor, you are not suitable for this type of study for any other reason
  • You have had a serious allergic reaction to relevant medications in the past
  • You have taken part

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

Phase 3: approximately ~65% 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 3
Sponsor
Avid Radiopharmaceuticals
Registry
clinicaltrials_gov
Start date
1 October 2012
Est. completion
1 February 2013

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Qualitative Amyloid Image Assessment; Mean Cortical to Cerebellum SUVR

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