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

NCT04141150 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: APN-1607-201
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief Summary

The overall objective of this study is to compare the overall pattern of \[18F\]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.

Conditions

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

Keywords

AD; MDAD; HV

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).

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Secondary Outcomes (5)

• Number of Adverse Events (AEs)

  Day 7

• Number of Serious Adverse Events (SAEs)

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• Number of participants with vital sign abnormalities

  Day 7

• Number of participants with ECG abnormalities

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• Number of participants with clinical laboratory abnormalities

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Study Arms (1)

[18F]APN-1607

EXPERIMENTAL

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

Drug: [18F]APN-1607

Interventions

[18F]APN-1607 DRUG

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

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.
• Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method (ie, condom), or to abstinence for the study duration.
• Male subjects must not donate sperm for the study duration.
• Willing and able to participate in all study procedures.
• Written informed consent must be obtained before any assessment is performed.
• Medically healthy with no clinically relevant finding on physical examination, laboratory profiles, VS, or ECG at screening and upon reporting for the \[18F\]APN-1607 Imaging Visit.
• No cognitive impairment based on neuropsychological battery and as judged by the Investigator.
• No first-degree family history of early-onset AD or other neurodegenerative disease associated with dementia (prior to age 65).
• Has a clinical dementia rating (CDR) score of 0.
• Has an MMSE score ≥ 27.
• The subject has an appropriate informant to accompany the subject to screening to provide information for the CDR testing. In the event that the informant cannot accompany the subject to screening, the interview may be performed via phone, at the discretion of the site Investigator.
• Written informed consent must be obtained before any assessment is performed.
• Must meet all of the clinical criteria for MCI according to NIA-AA criteria, including lack of functional impairment sufficient to warrant a diagnosis of dementia.
• Has a CDR score = 0.5.

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.

Sponsors & Collaborators

• APRINOIA Therapeutics, LLC: lead

Study Sites (3)

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

New Haven, Connecticut, 06510, United States

Location

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

Mount Arlington, New Jersey, 07856, United States

Location

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

Location

Related Links

• Description Related Information

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental 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
• Primary Completion: September 1, 2024
• Study Completion: February 1, 2025
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (3)