Trials Sponsors Conditions Drugs Pricing

Conditions

Alzheimer's Disease Healthy Volunteers Mild Cognitive Impairment Due to Alzheimer's Disease

Keywords

ADMDADHV

Outcome Measures

Primary Outcomes (1)

Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values
Regional \[18F\]APN-1607 uptake patterns will be assessed in regions of interest (ROIs) and an iROI that are relevant to AD pathology. \[18F\]APN-1607 uptake patterns identified by regional analysis will be compared among healthy subjects, subjects with MDAD, and subjects with AD dementia. Standard uptake value (SUV) will be calculated for each ROI, and SUVRs will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region. Mean and standard deviation of \[18F\]APN-1607 uptake (ie, SUVR) will be calculated across healthy, MDAD and AD dementia cohorts. Differences between groups will be tested at a P-value of 0.05 using statistical analyses methods (eg, unpaired t-test, ANOVA).
Day 7

Secondary Outcomes (5)

Number of Adverse Events (AEs)
Day 7
Number of Serious Adverse Events (SAEs)
Day 7
Number of participants with vital sign abnormalities
Day 7
Number of participants with ECG abnormalities
Day 7
Number of participants with clinical laboratory abnormalities
Day 7

Study Arms (1)

[18F]APN-1607

EXPERIMENTAL

Subjects will undergo PET imaging using \[18F\]APN-1607.

Drug: [18F]APN-1607

Interventions

[18F]APN-1607Drug

In this study, all patients will receive one injection of \[18F\]APN-1607, a PET radiopharmaceutical selective for fibrillar tau. For the injection, subjects will receive a target dose of 7 mCi IV as a bolus injection. \[18F\]APN-1607 injection will be followed by a 10 ml saline flush.

[18F]APN-1607

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males or females aged 50 to 85 years, inclusive.
Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year (ie, 12 consecutive months with no menses without an alternative medical cause) or, if they are of childbearing potential, must commit to using a barrier contraception method or to abstinence for the duration of the study and must have a negative pregnancy test.

Sponsors & Collaborators

APRINOIA Therapeutics, LLC
Industrylead

Study Sites (3)

Invicro (Site 100), 60 Temple Street, 8th Floor

New Haven, Connecticut, 06510, United States

The NeuroCognitive Institute (Site 103), 111 Howard Blvd., Suite 204

Mount Arlington, New Jersey, 07856, United States

Columbia University Irving Center for Clinical and Translational Research (Site 105), 622 West 168th Street, PH-10th Floor

New York, New York, 10032, United States

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

David Russell, M.D., Ph.D
Invicro
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 28, 2019

Study Start

March 22, 2022

Actual (reported)

Primary Completion

September 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

Current or prior history (within the last 10 years) of alcohol or drug abuse.
Known hypersensitivity to \[18F\]APN-1607 or its excipients
Clinically significant active or unstable medical illness or planned surgical procedures during the study period. History of cancer (other than non-melanoma skin cancers or stable, local prostate cancer), unless without evidence of active disease within the last 3 years and without ongoing medical or surgical therapy.
Laboratory tests with clinically significant abnormalities or a history or evidence of clinically significant unstable medical illness.
Has received any investigational drug or device for any purpose within 30 days of screening (or 5 halflives of the drug, whichever is longer), has received a non-biologic investigational treatment (ie, small molecule) for AD or other cause of dementia within the last 3 months (or 5 half-lives of the drug, whichever is longer), or received a non-vaccine treatment (ie, monoclonal antibody) for the treatment of AD or other cause of dementia within the last 6 months, or has ever received a vaccine for the treatment of AD or other cause of dementia.
Prior participation in other research protocols or clinical care in the last year in which the additional radiation exposure expected from participation in this clinical study will together exceed local guidelines, eg, above an effective dose of 50 mSv in the US.
Pregnant, lactating or breastfeeding.
Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
Unsuitable veins for repeated venipuncture.
Implants, such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI unless an acceptable MRI obtained in the 1 year prior to participation in the study is used.
Signs or symptoms suggestive of active Coronavirus disease 2019 (COVID-19) and/or confirmed diagnosis of COVID-19, or positive COVID-19 polymerase chain reaction (PCR) test in the previous 2 weeks. These subjects should not be enrolled until 4 weeks after full recovery and further assessment by the Investigator per institutional guidelines. A subject with a known history of being exposed to someone who was diagnosed of COVID-19, during the prior 4 weeks, should not be enrolled unless the infection is excluded by local practice or institution.
Meets criteria for a diagnosis of MDAD or dementia or has ever had such a diagnosis.
Has ever received treatment with a drug for cognitive impairment or dementia.
\. Meets criteria for a diagnosis of dementia due to AD.

Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

[18F]APN-1607

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

[18F]APN-1607

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations