Recruiting PHASE3 Alzheimer Disease

New treatment option for Alzheimer Disease

Official title Biomarker Exploration in Aging, Cognition and Neurodegeneration

ClinicalTrials.gov ID: NCT03860857

What this study is testing

What is Tau PET scan using MK-6240?

Tau PET scan using MK-6240 is an investigational medicine, being studied as a potential treatment for alzheimer disease.

Also referred to as tau PET.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The purpose of this research study is to understand the factors that underlie changes in thinking and memory with increasing age. The investigators will test the usefulness of MRI, PET, and cognitive testing in detecting subtle changes in the brain that precede cognitive decline.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 60 and older. Healthy volunteers may be eligible.

You may be able to join if

  • Aged 60 or older;
  • Speaks fluent English or Spanish;
  • Visual and auditory acuity adequate for neuropsychological and computerized testing;
  • Good general health with no disease(s) expected to interfere with the study;
  • Willing and able to participate for the duration of the study and in all study procedures including MRI and PET;

You likely can't join if

  • Significant co-morbid neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm;
  • Major health conditions, except for Type II diabetes mellitus, hypercholesterolemia, and hypertension, which are NOT exclusionary for this study...
  • Significant psychiatric disorders such as schizophrenia, bipolar disorder, or attention-deficit hyperactivity disorder, except for depression and...
  • Existing diagnosis of dementia or mild cognitive impairment;
  • Alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria);
  • MRI contraindications, e.g. pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin...
See the full eligibility criteria
Who can join
  • Aged 60 or older;
  • Speaks fluent English or Spanish;
  • Visual and auditory acuity adequate for neuropsychological and computerized testing;
  • Good general health with no disease(s) expected to interfere with the study;
  • Willing and able to participate for the duration of the study and in all study procedures including MRI and PET;
  • Normal cognition defined as a Clinical Dementia Rating of 0 and a Mini-Mental State Examination score of 25 or higher. FAST Stage 1 or 2.
  • Subjective memory or other cognitive complaints will be included.
What rules you out
  • Significant co-morbid neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm;
  • Major health conditions, except for Type II diabetes mellitus, hypercholesterolemia, and hypertension, which are NOT exclusionary for this study given their high prevalence in our target populations;
  • Significant psychiatric disorders such as schizophrenia, bipolar disorder, or attention-deficit hyperactivity disorder, except for depression and anxiety, which are NOT exclusionary for this study given their high...
  • Existing diagnosis of dementia or mild cognitive impairment;
  • Alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria);
  • MRI contraindications, e.g. pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body. Females who are pregnant or trying to get pregnant are also...
  • PET contraindications, e.g. significant prior radiation exposure and pregnancy.

The study team makes the final eligibility decision.

Where it's taking place

  • Irvine, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.