Start: October 26, 2020
End: July 31, 2023
What Is This Study About?
Tau is a protein that forms tangles in brain cells, one of the hallmarks of Alzheimers disease. During a tau PET brain scan, small amounts of a radioactive marker are used to visualize tau in the brain. This Phase 1 study will compare the safety and ability of three different radioactive markers to detect tau protein in the brain. Participants will be randomly assigned to one of two groups. Each group will undergo two PET brain scans to test different markers. Researchers will evaluate the amount of brain tau detected and monitor all participants for any side effects for four days after the brain scans.
Do I Qualify To Participate in This Study?
Participants With Early-Stage to Moderate Alzheimer's:
- Diagnosis of early-stage to moderate Alzheimer's with:
- Clinical Dementia Rating score of 0.5
- Mini-Mental State Examination score of 10 to 30 inclusive
- PET brain scan results that show amyloid deposits
- MRI brain scan results that support a diagnosis of early-stage or moderate Alzheimer's, with no evidence of other serious neurological disease
- Available study partner who can answer questions about participants memory and daily function
- Aged 50 to 90 years
Participants With Normal Cognition:
- Normal cognition with:
- Clinical Dementia Rating score of 0
- MRI and PET brain scans consistent with normal cognition
- History of at least one first-degree relative with a diagnosis of Alzheimer's
- Aged 65 to 90 years
Must NOT have:
- Current or history of alcohol or drug abuse within the past two years
- Prior radiation exposure that, when combined with study PET scan, would exceed annual radiation limits
- MRI evidence of cerebrovascular or other central nervous system disease, brain infection, or normal pressure hydrocephalus
- Any condition or implanted device that may make having an MRI brain scan unsafe (e.g., metal shrapnel, heart pacemaker, severe claustrophobia)
- Evidence of any serious medical condition that could interfere with the study, including:
- Digestive, lung, heart, liver, or kidney disease
- Hormone, blood, or immune conditions
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Reference Study ID Number: GN42801 https://forpatients.roche
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Invicro, a Konica Minolta company
New Haven, CT 06510
Lead: Genentech, Inc.
Source: ClinicalTrials.gov ID: NCT04566003