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

NCT04080544

NCT04080544
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You took part in Wave 1 or Wave 2 of a previous study called the DLBS study.
  • If you are a woman who could potentially become pregnant, you must confirm you are not currently pregnant and agree to use reliable birth control (such as hormonal methods, barrier methods, or abstinence) during the study and for 90 days after it ends.
  • You have had a specific type of brain MRI (called a T1-weighted MPRage) done as part of the DLBS Wave 1, 2, or 3 study.
  • You have completed at least 9 years of formal schooling (roughly up to freshman year of high school or beyond).
  • You are fluent in English.
  • You are able to lie flat and still on a table for about 20 minutes for a PET scan.
  • You are willing and able to understand and sign a written consent form to participate.

Who may not be able to join:

  • You scored lower than 22 on a standard memory and thinking test called the MMSE, which may suggest some decline in mental function.
  • You are currently taking certain sedatives, benzodiazepines (a type of calming medication), or antipsychotic medications.
  • You are currently receiving chemotherapy or radiation treatment for cancer.
  • You have a new history of substance misuse.
  • You have had a problem with drug or alcohol dependence in the past year, or had a long period of dependence in the past.
  • You have used recreational drugs in the past six months.
  • You have a disease or injury affecting the brain or nervous system that would prevent safe participation.
  • You have a psychiatric or neurological condition that would prevent safe participation.
  • You have significant health problems affecting your liver, kidneys, lungs, metabolism, or hormones that could put you at risk.
  • You have a significant heart or cardiovascular condition that could put you at risk.
  • You currently have a significant infectious disease or other medical condition that could put you at risk.
  • Your heart's electrical activity (measured by an ECG test) shows a reading outside safe limits, or you have certain heart rhythm risk factors or take medications known to affect heart rhythm (confirm with trial site).
  • You have taken or will take any experimental medication within 30 days of your PET/CT scan.
  • You have received or will receive a radioactive substance for imaging or treatment within 24 hours of your PET/CT scan.
  • The study investigators have another reason to believe the study would not be appropriate for you (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

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

Phase 2: approximately ~30% 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 2
Sponsor
Neil M Rofsky, MD, MHA
Registry
clinicaltrials_gov
Start date
15 January 2019
Est. completion
30 June 2022

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Standardized Uptake Value Ratios (SUVrs) Calculated From [18F]AV-1451 PET Scans

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