UnknownPhase 1 / PHASE2

Biomarker Study: Heart Failure Patients at Risk

Biomarker Study: Heart Failure Patients at Risk for Vascular Dementia and Alzheimer's Disease Related Dementia [Supplement of: IND Enabling Studies for a Novel Mas Receptor Agonist for Treatment of Cognitive Impairment in Patients at Risk for Alzheimer's Disease Related Dementia]

Lead sponsor

University of Arizona

Asset

Angiotensin 1-7

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criteria

•Age ≥45•MRI contraindications excluded

Primary endpoints

•Baseline Blood Biomarkers - Neurology 4-Pleax A, pTau-181, and pTau 231•Baseline evaluations of associative, verbal memory•Baseline evaluations of associative, visual memory

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2106885512

NCT IDNCT05336175

Timeline

Milestones

Study start2022-04estimated (month precision)

Study first posted2022-04-20actual

Last update posted2022-04-20actual

Primary completion2023-12estimated (month precision)

Study completion2023-12estimated (month precision)

Assets

Drug assets

Angiotensin 1-7

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age45 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants may be included in the study if they are:

-45 years old and older

-Diagnosed at least 90 days prior to enrollment with stable NYHA Class II-IV HF, with symptoms during mild or moderate exercise but not at rest (i.e., shortness of breath),

-On a stable medical regimen and free from hospitalizations in the prior 30 days,

-Fluent English speakers

Exclusion criteria

•Participants will be excluded from the study if there is evidence of:

-Decompensated heart failure

-Symptoms or signs of active coronary ischemia

-Systolic blood pressure <95 mmHg

-Significant lung disease (FEV1< 1.5 L, pO2 <70 on room air, pCO2 >45)

-Active substance abuse or a history of substance abuse with cocaine, ecstasy, LSD, or IV drugs

-History of or current seizure disorder or on medications for seizures (with the exception of childhood febrile seizures)

-Neurological, psychiatric, or medical illness or injury expected to interfere with cognitive function including but not limited to stroke, head injury, Alzheimer's, Parkinson's, or brain cancer

-Current depression (Patient Health Questionnaire-9 score >10)

-Any condition which may prevent the subject from adhering to the study protocol such as significantly impaired vision.\\

Note: Participants that have contraindications for MRI may be enrolled, but will not take part in the MRI portion of the study.

Endpoints (42)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Executive function / language

Other (unclassified)

Function / daily living

Global cognition

Tau biomarkers

Behavior / neuropsychiatric

Caregiver / quality of life

Other clinical outcomes

Global cognition

3 endpoints

Primary/protocol endpoint

Baseline evaluations of global cognitive functioning as measured by the Montreal Cognitive Assessment

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

12-week evaluations of global cognitive functioning as measured by the Montreal Cognitive Assessment

Time frame:These measurements will be taken after the 12 week drug course

descriptive

Primary/protocol endpoint

12-month evaluations of global cognitive functioning as measured by the Montreal Cognitive Assessment

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Memory

12 endpoints

Primary/protocol endpoint

Baseline evaluations of associative, verbal memory as measured by the verbal paired associates task (version 2)

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

Baseline evaluations of associative, visual memory as measured by the Face Name Associative Memory Test

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

Baseline evaluations of pattern separation memory as measured by the Mnemonic Similarity Task

Time frame:These measurements will be taken at baseline

ratio, descriptive

Primary/protocol endpoint

Baseline evaluations of executive functions - updating/working memory as measured by the Keep Track Task

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

12-week evaluations of associative, verbal memory as measured by the verbal paired associates task (version 2)

Time frame:These measurements will be taken after the 12 week drug course

descriptive

Primary/protocol endpoint

12-week evaluations of associative, visual memory as measured by the Face Name Associative Memory Test

Time frame:These measurements will be taken after the 12 week drug course

descriptive

Primary/protocol endpoint

12-week evaluations of pattern separation memory as measured by the Mnemonic Similarity Task

Time frame:These measurements will be taken after the 12 week drug course

ratio, descriptive

Primary/protocol endpoint

12-week evaluations of executive functions - updating/working memory as measured by the Keep Track Task

Time frame:These measurements will be taken after the 12 week drug course

descriptive

Primary/protocol endpoint

12-month evaluations of associative, verbal memory as measured by the verbal paired associates task (version 2)

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Primary/protocol endpoint

12-month evaluations of associative, visual memory as measured by the Face Name Associative Memory Test

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Primary/protocol endpoint

12-month evaluations of pattern separation memory as measured by the Mnemonic Similarity Task

Time frame:These measurements will be taken at the 12 month follow up

ratio, descriptive

Primary/protocol endpoint

12-month evaluations of executive functions - updating/working memory as measured by the Keep Track Task

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Executive function / language

9 endpoints

Primary/protocol endpoint

Baseline evaluations of executive functions - switching as measured by the Number-Letter Task

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

Baseline evaluations of executive functions - attention/inhibition as measured by the Flanker Task

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

Baseline evaluations of processing speeds - simple/complex processing speeds as measured by the Deary-Liewald Reaction Time Task

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

12-week evaluations of executive functions - switching as measured by the Number-Letter Task

Time frame:These measurements will be taken after the 12 week drug course

descriptive

Primary/protocol endpoint

12-week evaluations of executive functions - attention/inhibition as measured by the Flanker Task

Time frame:These measurements will be taken after the 12 week drug course

descriptive

Primary/protocol endpoint

12-week evaluations of processing speeds - simple/complex processing speeds as measured by the Deary-Liewald Reaction Time Task

Time frame:These measurements will be taken after the 12 week drug course

descriptive

Primary/protocol endpoint

12-month evaluations of executive functions - switching as measured by the Number-Letter Task

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Primary/protocol endpoint

12-month evaluations of executive functions - attention/inhibition as measured by the Flanker Task

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Primary/protocol endpoint

12-month evaluations of processing speeds - simple/complex processing speeds as measured by the Deary-Liewald Reaction Time Task

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Function / daily living

4 endpoints

Primary/protocol endpoint

Participants disability due to health/mental health conditions will be assessed as measured by the World Health Organization Disability Assessment Schedule 2.0

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

Participants independent living skills will be assessed as measured by the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L)

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

Participants disability due to health/mental health conditions will be assessed as measured by the World Health Organization Disability Assessment Schedule 2.0

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Primary/protocol endpoint

Participants independent living skills will be assessed as measured by the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L)

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Participants sleep quality will be assessed as measured by the Pittsburgh Sleep Quality Index

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

Participants sleep quality will be assessed as measured by the Pittsburgh Sleep Quality Index

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Tau biomarkers

3 endpoints

Primary/protocol endpoint

Baseline Blood Biomarkers - Neurology 4-Pleax A, pTau-181, and pTau 231 as measured by the Quanterix Simoa Neurology 4-plex A and Simoa pTau-181 and 283 advantage kits

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

12-week Blood Biomarkers - Neurology 4-Pleax A, pTau-181, and pTau 231 as measured by the Quanterix Simoa Neurology 4-plex A and Simoa pTau-181 and 283 advantage kits

Time frame:These measurements will be taken after the 12 week drug course

descriptive

Primary/protocol endpoint

12-month Blood Biomarkers - Neurology 4-Pleax A, pTau-181, and pTau 231 as measured by the Quanterix Simoa Neurology 4-plex A and Simoa pTau-181 and 283 advantage kits

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Caregiver / quality of life

2 endpoints

Primary/protocol endpoint

Participants quality of life will be assessed as measured by the World Health Organization Quality of Life - BREF (WHOQOL-BREF)

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

Participants quality of life will be assessed as measured by the World Health Organization Quality of Life - BREF (WHOQOL-BREF)

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Participants physical activity will be assessed as measured by Rapid Assessment of Physical Activity

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint

Participants physical activity will be assessed as measured by Rapid Assessment of Physical Activity

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

Baseline evaluations of reading ability/vocabulary as measured by the North American Reading Test

Time frame:These measurements will be taken at baseline

descriptive

Primary/protocol endpoint/low confidence

Participants heart failure health status will be assessed as measured by the Kansas City Cardiomyopathy Questionnaire

Time frame:These measurements will be taken at baseline

categorical status, descriptive

Primary/protocol endpoint/low confidence

12-week evaluations of reading ability/vocabulary as measured by the North American Reading Test

Time frame:These measurements will be taken after the 12 week drug course

descriptive

Primary/protocol endpoint/low confidence

12-month evaluations of reading ability/vocabulary as measured by the North American Reading Test

Time frame:These measurements will be taken at the 12 month follow up

descriptive

Primary/protocol endpoint/low confidence

Participants heart failure health status will be assessed as measured by the Kansas City Cardiomyopathy Questionnaire

Time frame:These measurements will be taken at the 12 month follow up

categorical status, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.