Back to Alzheimers Disease
NCT01662882
NCT01662882
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?
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.