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.
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
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).
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- 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.
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
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:
- Will elderly patients with mild cognitive impairment be able to tolerate taking a daily, low dose (5 mg) of tadalafil?
- Does 5 mg of daily tadalafil improve cerebral vasomotor reactivity (i.e. vascular function) and cognition?
Read more
Participants will to:
- Answer questions about your health
- Take three short thinking and memory tests
- Have your blood pressure and heart rate checked
- Have an electrocardiogram
- Fill out a thinking questionnaire
- Fill out a suicidality questionnaire
- Have a brain blood flow test
- Get three blood tests throughout the study
- Take tadalafil once daily
- Monitor your blood pressure twice daily
- Record any side effects
- Return after 4 weeks and repeat testing
- Conditions
- Mild Cognitive Impairment (MCI)
- 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 group | Role | What they receive |
|---|---|---|
| Tadalafil (5 mg) | Experimental | Participants 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.
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)
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
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
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
Neurocognitive Testing
- 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).
- 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
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.
- First posted20 Oct 2026
- Study startSep 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Los Angeles Brain Science Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Franc, MD, PhD, Principal investigator, Los Angeles Brain Science Project
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)