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Mild Cognitive Impairment (MCI)Phase 2NCT07882901

Effects of Tadalafil on Cognition and Cerebral Hemodynamics in Elderly Patients With Mild Cognitive Impairment

A Phase 2 study testing Tadalafil 5 mg in people with Mild Cognitive Impairment (MCI), run by Los Angeles Brain Science Project at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to determine if taking four weeks of a daily low dose of tadalafil is possible and safe in elderly males and females with mild cognitive impairment. Read more about this study

Who is it for?
Ages 60 to 90 years
Conditions the study is for
Mild Cognitive Impairment (MCI)
What is being tested?
Tadalafil 5 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Sep 2026to 20 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant is between the ages of 60-90 years old.
  • The participant must demonstrate a MoCA score ≥ 18 and ≤ 25.
  • The participant has consented for his/herself.
  • The participant has a caregiver, family member, or qualified individual to help with study tasks
  • The participant is fluent in the English language.
  • The participant is proficient in comprehending verbal and written English.

Who cannot join

  • Any of the aforementioned CMP values meet the exclusion threshold.
  • Absence of a caregiver, family member, or other appropriately qualified individual that will be available for the entire experimental duration to assist the participant with study tasks, including supervision of medication intake, recording blood pressure, and noting adverse events.
  • Current use of any form of organic nitrates or nitrite-containing medications, or planned nitrate use within 48 hours of tadalafil dosing.
  • Known hypersensitivity to tadalafil or to any component of the formulation.
  • Recent (within prior 3 months) acute cardiovascular events - e.g., myocardial infarction, unstable angina, stroke, or life-threatening cardiac arrhythmia - or decompensated/unstable heart failure according to the New York Heart Association (NYHA) class II-IV.
  • Resting hypotension (systolic BP <90 mmHg) or clinically significant symptomatic orthostatic hypotension, or uncontrolled severe hypertension (e.g., systolic BP >170 mmHg or diastolic BP >110 mmHg).
Show all 25Show fewer
  • Concurrent use of potent CYP3A4 inhibitors, including but not limited to:
  • Amiodarone ii. Aprepitant iii. Azamulin iv. Cimetidine v. Ciprofloxacin vi. Clarithromycin vii. Diltiazem viii. Erythromycin ix. Fedratiib x. Fedratinib xi. Fluconazole xii. Itraconazole xiii. Ketoconazole xiv. Letermovir xv. Nirmatrelvir-Ritonavir xvi. Posaconazole xvii. Troleandomycin xviii. Voriconazole xix. Verapamil xx. Grapefruit and Grapefruit Juice xxi. Seville Orange Juice xxii. Pomelo Juice xxiii. Green tea extract xxiv. Curcumin/tumeric xxv. Black pepper extract xxvi. Goldenseal xxvii. Gingko Biloba xxviii. Kava xxix. Kratom xxx. CBD oil xxxi. Ginger xxxii. Elderberry Extract
  • Concurrent use of alpha-adrenergic blockers (unless on a stable dose and the investigator documents that coadministration is acceptable and that BP monitoring and dosing separation strategies are in place).
  • Severe renal impairment or end-stage renal disease (ESRD) on hemodialysis, and other renal dysfunction that, per the tadalafil product labeling, would contraindicate or require specific dosing changes for the intended tadalafil regimen.
  • Documented hepatic impairment, defined by Child Pugh Class A, B, or C.
  • History of non-arteritic anterior ischemic optic neuropathy (NAION), prior vision loss attributed to a PDE-5 inhibitor, or hereditary retinal disorders (e.g., retinitis pigmentosa).
  • Conditions that predispose to priapism (e.g., sickle cell disease, multiple myeloma, leukemia) if sexually active participants are at risk from prolonged erections.
  • Medical, neurologic, or psychiatric conditions (including advanced dementia) that, in the investigator's judgment, would preclude safe participation, study compliance, or the ability to provide informed consent.
  • Participants on guanylate cyclase (GS) stimulators such as riociguat (Adempas)
  • Participants with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis).
  • Participants with severe autonomic dysfunction.
  • Participants with known or suspected pulmonary veno-occlusive disease.
  • Participants with known hereditary degenerative retinal disorders, including retinitis pigmentosa, and those with underlying non-arteritic anterior ischemic optic neuropathy (NAION) risk factors.
  • Participants with active peptic ulceration or significant bleeding disorders.
  • Participants on other phosphodiesterase-5 (PDE5) inhibitors (sildenafil, vardenafil, avanafil).
  • Participants with an anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).
  • Participants with any uncontrolled arrhythmia, as determined by the screening electrocardiogram.
  • Participants with a creatinine clearance less than 30 mL/min.
  • Participants with a history of substantial alcohol consumption (≥ 5 units per day)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Trent Yamamoto, MS contact

818-900-0611

research@losangelesbrain.com

United States1 site

  • Los Angeles Brain Science Project

    Santa Monica, California, 90403

    Trent Yamamoto, MS, 818-900-0611, research@losangelesbrain.com

    Daniel Franc, MD, PhD

Other trials in United States

About this study

Official title: Assessing the Feasibility of Daily Low Dose Tadalafil and Subsequent Effects on Cognition and Cerebral Vasomotor Reactivity in Elderly Patients With Mild Cognitive Impairment

The goal of this clinical trial is to determine if taking four weeks of a daily low dose of tadalafil is possible and safe in elderly males and females with mild cognitive impairment. Additionally, we aim to determine if this drug that improves blood flow can improve cognition and functionality of the blood vessels in the brain. The main questions the trial aims to answer are:

  1. Will elderly patients with mild cognitive impairment be able to tolerate taking a daily, low dose (5 mg) of tadalafil?
  2. Does 5 mg of daily tadalafil improve cerebral vasomotor reactivity (i.e. vascular function) and cognition?
Read more

Participants will to:

  1. Answer questions about your health
  2. Take three short thinking and memory tests
  3. Have your blood pressure and heart rate checked
  4. Have an electrocardiogram
  5. Fill out a thinking questionnaire
  6. Fill out a suicidality questionnaire
  7. Have a brain blood flow test
  8. Get three blood tests throughout the study
  9. Take tadalafil once daily
  10. Monitor your blood pressure twice daily
  11. Record any side effects
  12. Return after 4 weeks and repeat testing
Being tested
Tadalafil 5 mg
Keywords
Mild Cognitive Impairment (MCI), Tadalafil
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tadalafil 5 mgDrug

    Participants will take a daily dose of 5 mg of tadalafil over a 4 week period

Study groups in NCT07882901
Study groupRoleWhat they receive
Tadalafil (5 mg)ExperimentalParticipants will take a daily dose of 5 mg of tadalafil over a 4 week period
Receives: Drug: Tadalafil 5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance (%) with tadalafil

    Assessed as the value equal to 100 x (number of dispensed tablets - returned tablets) / (planned days on trial medication)

    Measured: From beginning to the end of treatment at four weeks

Secondary outcomes (5)

  1. Cerebrovascular Reactivity to Hypercapnia

    Measured using transcranial doppler ultrasonography (TCD) of the bilateral middle cerebral arteries and breath-holding test (BHT) techniques

    Measured: Baseline (pre-) and post-intervention at 4 weeks

  2. Resting Heart Rate

    Resting heart rate (bpm) measured using the OMRON BP7000 Evolv Upper Arm monitor

    Measured: Resting heart rate measured at baseline (pre-) and post-intervention at 4 weeks

  3. Blood Pressure

    Blood pressure (mmHg) measured using the OMRON BP7000 Evolv Upper Arm monitor

    Measured: Baseline, twice daily throughout the study (i.e. 4 weeks), and post-intervention at 4 weeks

  4. Neurocognitive Testing

    1. Fatigue and Altered Cognition Scale (FACs) - 20 item questionnaire equally divided into 10 categories designed to determine altered cognition and another 10 categories to assess central fatigue within the previous two weeks. Each item operates under a 0 (not at all) - 100 (extremely), with higher scores indicating feeling more aligned with the statement or symptom(s).
    2. Creyos Cognitive Assessment - brief assessment of attention, mental rotation, deductive and verbal reasoning, and visuospatial and episodic memory. Each domain is graded on a sex- and age-specific standardized scale with no fixed minimum or maximum value. Distributions operate with a mean score = 100 and standard deviation = 15. Demographic-specific scales are used to describe the results, including scores ≤ 87 described as "Below average," scores ≥ 113 described as "Above average," and all scores between these two bounds described as "Average."

    Measured: Baseline (pre-) and post-intervention at 4 weeks

  5. Adverse Events

    Any and all adverse side-effects experienced while taking tadalafil will be documented using a written paper-based log. Summarization of adverse events, characterized by frequency and severity, will be facilitated

    Measured: During the intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study startSep 2026 (estimated)
  3. Primary completion20 Feb 2027 (estimated)
  4. Study completion20 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07882901
Sponsor's protocol ID
Pro00091971
Status last verified
Oct 2026
First submitted
28 Sep 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD used in the results of resulting publication(s)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tadalafil 5 mg in people with Mild Cognitive Impairment (MCI), run by Los Angeles Brain Science Project at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trent Yamamoto, MS (818-900-0611, research@losangelesbrain.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance (%) with tadalafil (time frame: From beginning to the end of treatment at four weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07882901.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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