ClinicalTrials.gg
CompletedNCT06597058Updated Apr 8, 2026

Phase 2 Estimation Study of Fixed Dose Drugs Combination Type of Polypill

A Phase 2 interventional study of MAR in Alzheimer Disease, sponsored by Noah Pharmaceuticals, Inc.. Completed at 16 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Noah Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2025, 1 year ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study summary

This is an estimation-focused Phase 2 study designed to explore and quantify treatment-related changes across multiple clinical outcomes in patients with Alzheimer's disease over a 210-day period. The anticipated study population are males and females aged 50-85 years with very mild to severe Alzheimer's Disease. The duration of individual patient participation will be approximately 224 Days: up to 14 days for Screening, 180 days for study drug administration, and a final follow-up visit at 210 days. The planned study duration is 12-18 months from Screening of the first patient until the last follow-up of the last patients.

02

Conditions studied

  • Alzheimer Disease

Keywords

  • Dementia
  • Neurodegeneration
  • Cognitive Impairments
  • Mental Deterioration
  • Loss of Memory
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's enrollment of 121 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

This is the only study on the registry with Noah Pharmaceuticals, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Prior diagnosis of mild-to-severe cognitive impairment or probable AD according to the National Institute on Aging and the Alzheimer's Association guidelines by a qualified health practitioner;
  2. History of cognitive and functional decline over at least 1 year that is either documented in medical records or by history from an informant who knows the patient well;
  3. Male or female, age 50 to 85 years (inclusive) at the Screening Visit;
  4. Patient must be ambulatory and reside with a reliable, competent adult (study partner) who may or may not also be the patient's legally authorized representative (LAR) for ;
  5. Patient must be able to swallow the study medication (without any alteration to the tablet like crushing, cutting in half, or dissolving in a liquid);
  6. Body weight at screening is ≥40kg;
  7. CDR-SB of 3.0 or higher at Screening Visit;
  8. -2 ≥8 and≤24 at the Screening Visit;
  9. Patient must be able to understand the nature of the study and have the opportunity to have any questions answered and provide their consent. In the absence of patient's ability to provide informed consent, the informed consent must be obtained from the patient's Legally Authorized Representative (LAR);
  10. For patients receiving an anticholinesterase inhibitor, memantine, or herbal medication for AD, the dose must have been stable for at least 3 months prior to the Screening Visit, and patient must agree to maintain this dose for the duration of the study;
  11. Patients currently treated with a statin must agree to stop their statin therapy for the duration of treatment (180 days);
  12. >30 mL/min at Screening;
  13. Negative and test at Screening;
  14. Complete blood count (CBC), blood chemistry, serum cholesterol, triglycerides, thyroid-stimulating hormone (TSH), and urinalysis, within normal reference ranges or not as assessed by the Investigator at Screening;
  15. Physical examination, vital signs, and within normal ranges or not clinically significant as assessed by the Investigator at Screening;
  16. Female patients may participate if they meet 1 of the following criteria:

    1. Surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or
    2. , defined as
    3. Permanent cessation of menstruation for ≥12 months without an alternative medical cause (regardless of follicle-stimulating hormone [FSH] value) at the Screening Visit, or
    4. Cessation of menstruation for \<12 months and FSH >40 mIU/mL at the Screening Visit.

    Note: Patients with persistent menses due to hormonal therapy may participate if a urine pregnancy test (UPT) at the Screening Visit is negative and they agree to continued testing at every study visit.

  17. Male patients must agree to use a barrier method of and refrain from donating sperm for the duration of their participation in the study and for 2 months thereafter.

Exclusion criteria

Exclusion Criteria:

  1. Patient has had a myocardial infarction, unstable angina, stroke, or required intervention for any of these conditions (e.g., coronary artery bypass graft, percutaneous coronary intervention via cardiac catheterization, thrombolytic therapy) within 6 months of the Screening Visit;
  2. Has other neurological disorders, including vascular dementia, Parkinson's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, neurosyphilis, dementia with Lewy bodies, other types of dementia, mental retardation, hypoxic cerebral damage, and cognitive impairment from head trauma;
  3. Scheduled or anticipates vaccination with a during the study;
  4. Current use of a cannabidiol or derivative;
  5. Current use of digoxin;
  6. Acute or chronic liver disease;
  7. >1.5 times the
  8. ALT > 1.5 times the Upper Limit of Normal
  9. Schizophrenia, bipolar disorder, suicidal ideation, major depression, or delirium; Note: Stable (>2 years) treated depression without suicidal ideation is acceptable;
  10. Current therapy with a tetracycline;
  11. Current therapy with sirolimus or a rapalog macrolide antibiotic;
  12. Known allergies to any of the active drugs: tetracycline antibiotics, rapalog macrolide antibiotics, or statin therapies;
  13. Treatment with another drug, device, or intervention within 30 days prior to the Screening Visit;
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
121 participants (actual)

Study arms

  • Experimental
    MAR COMBO

    MAR Active 0.6 g, Tablet, once-daily, 180 days

    Drug: MAR

  • Placebo comparator
    MAR PLACEBO

    MAR Placebo 0.6 g, Tablet, once-daily, 180 days

    Drug: MAR

Interventions

  • DrugMAR

    Once-daily tablet

06

What researchers measure

Primary outcomes

  1. Clinical Dementia Rating - Global Score

    CDR - Global Score: To estimate the magnitude and variability of clinical response to a drug combination Tablet in patients with Alzheimer's disease (AD) after 180 days of treatment against Placebo Tablet. The CDR scale is a widely used dementia staging instrument that produces a global score. This study will use global score for estimation, comparisons and analysis. The global score ranges from 0 to 3. The sites are instructed to use a standardized online calculator for scoring. This resulting calculation reflects the following scoring 0 = normal, no cognitive impairment; 0.5 = very mild dementia, minimal impairment in one domain; 1 = mild dementia, noticeable impairment in one or more domains; 2 = moderate dementia, significant impairment in multiple domains; 3 = severe dementia, major impairment in multiple domains.

    Time frame: Day 210

  2. Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

    CDR - SB: To estimate the magnitude and variability of clinical response to a drug combination Tablet in patients with Alzheimer's disease (AD) after 180 days of treatment against Placebo Tablet. The CDR scale is a widely used dementia staging instrument that produces a summated score (sum of boxes score). This study will use the summated score, comparisons and analysis. The "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in of 0.5 or greater. Higher scores indicate greater disease severity. A positive change from baseline indicates clinical decline. Score Range from 0 to 18. Response choices are 0 = normal; 0.5 to 2.5 = questionable impairment; 3.0 to 4.0 = very mild dementia; 4.5 to 9.0 = mild dementia; 9.5 to 15.5 = moderate dementia; 16.0 to 18.0 = severe dementia.

    Time frame: Day 210

  3. Mini-Mental Scale Evaluation, 2nd Edition (MMSE-2) Score

    MMSE-2: To estimate the magnitude and variability of clinical response to a drug combination Tablet in patients with Alzheimer's disease (AD) after 180 days of treatment against Placebo Tablet. The MMSE-2 is a widely used test of cognitive function among the elderly. The Standard Version consists of a 30-point questionnaire that includes tests of orientation, attention, memory, language, and visual-spatial skills. Score Range from 0 to 30. Response choices are 30 = normal; 26 to 29 = mild cognitive impairment; 21 to 25 = early stage dementia or mild cognitive impairment; 11 to 20 = middle stage dementia or moderate cognitive impairment; 0 to 10 = late stage dementia or severe cognitive impairment.

    Time frame: Day 210

  4. Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-COG)

    ADAS-COG: To estimate the magnitude and variability of clinical response to a drug combination Tablet in patients with Alzheimer's disease (AD) after 180 days of treatment against Placebo Tablet. The ADAS-COG is used to assess cognitive symptoms of dementia. It consists of 7 performance items and 4 clinician-rated items assessing memory, orientation, language and praxis. Score Range from 0 to 70. Response choices are 0 to 10 = minimal to no cognitive impairment; 11 to 20 = mild cognitive impairment; 21 to 30 = moderate cognitive impairment; 31 to 70 = severe cognitive impairment.

    Time frame: Day 210

  5. Alzheimer's Disease Cooperative Study-ADL scale (ADCS-ADL)

    ADCS-ADL: To estimate the magnitude and variability of clinical response to a drug combination Tablet in patients with Alzheimer's disease (AD) after 180 days of treatment against Placebo Tablet. The ADCS-ADL is a comprehensive battery of ADL questions used to measure the functional capabilities of patients; each item is rated from the highest level of independent performance to complete loss. Score Range from 0 to 78. Response choices are 0 to 20 = severe impairment; 21 to 40 = moderate impairment; 41 to 60 = mild impairment; 61 to 78 = minimal impairment.

    Time frame: Day 210

  6. Clinical Global Impressions - Improvement (CGI-I)

    CGI-I: To estimate the magnitude and variability of clinical response to a drug combination Tablet in patients with Alzheimer's disease (AD) after 180 days of treatment against Placebo Tablet. The Clinical Global Impressions-Improvement (CGI-I) scale will be assessed at all visits after Baseline. The Investigator (or designee) will answer the following question: "Compared to the patient's condition at Baseline. Score Range from 1 to 7. Response choices are: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change from Baseline; 5 = minimally worse; 6 = much worse; 7 = very much worse since Baseline".

    Time frame: Day 210

  7. Clinical Global Impressions - Severity (CGI-S)

    CGI-S: To estimate the magnitude and variability of clinical response to a drug combination Tablet in patients with Alzheimer's disease (AD) after 180 days of treatment against Placebo Tablet. The Clinical Global Impressions-Severity (CGI-S) scale will be assessed at Baseline and all visits afterward. The Investigator (or designee) will answer the following question: "Considering your total clinical experience with AD, how ill is the patient at this time?" Score Range from 1 to 7. Response choices are 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.

    Time frame: Day 210

  8. Clinical Dementia Rating - Global Score (Exploratory)

    Change from Baseline in the Clinical Dementia Rating - Global Score after 210 days (Global Score ranges from 0 to 3; a lower score indicates no disease; a higher score indicates greater disease severity; 0 = normal, 3 = severe dementia)

    Time frame: Day 210

  9. Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score (Exploratory)

    Change from Baseline in CDR-SB Score after 210 days (CDR-SB Score ranges from 0 to 18; a lower score indicates no disease; a higher score indicates greater disease severity; 0 = normal, 18 = severe dementia)

    Time frame: Day 210

  10. Mini-Mental Scale Evaluation, 2nd Edition (MMSE-2) Score (Exploratory)

    Change from Baseline from MMSE-2 Score through 210 days (MMSE-2 Score ranges from 0 to 30; a lower score indicates severe dementia; a higher score indicates better cognitive function; 0 to 10 = late stage dementia or severe cognitive impairment, 30 = normal)

    Time frame: Day 210

  11. Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-COG) (Exploratory)

    Change from Baseline in ADAS-COG Score through 210 days (ADAS-COG Score ranges from 0 to 70; a lower score indicates better cognitive function; a higher score indicates greater dysfunction; 0 to 10 = minimal to no cognitive impairment, 31 to 70 = severe cognitive impairment)

    Time frame: Day 210

  12. Alzheimer's Disease Cooperative Study-ADL scale (ADCS-ADL) (Exploratory)

    Change from Baseline in ADCS-ADL Score through 210 days (ADCS-ADL Score ranges from 0 to 78; a lower score indicates greater severity; a higher score indicates better functioning in daily activities; 0 to 20 = severe impairment, 61 to 78 = minimal impairment)

    Time frame: Day 210

  13. Clinical Global Impressions - Improvement (CGI-I) (Exploratory)

    Change from Baseline in CGI-I Score through 210 days (CGI-I Score ranges from 1 to 7; a lower score indicates the patient has improved; a higher score indicates the patient is very much worse since Baseline; 1 = very much improved, 7 = very much worse since Baseline)

    Time frame: Day 210

  14. Clinical Global Impressions - Severity (CGI-S) (Exploratory)

    Change from Baseline in CGI-S Score through 210 days (CGI-S Score ranges from 1 to 7; a lower score indicates the patient is less severely ill; a higher score indicates among the most extremely ill patients; 1 = normal, not at all ill, 7 = among the most extremely ill patients)

    Time frame: Day 210

  15. Treatment-emergent adverse events (TEAEs)

    Incidence of TEAEs through Day 210

    Time frame: Day 210

  16. Serious Adverse Events (SAEs)

    Incidence of SAEs from informed consent through Day 210

    Time frame: Day 210

  17. Adverse Events (AEs)

    Incidence of AEs from informed consent through Day 210

    Time frame: Day 210

07

Study locations

16 sites
  • Scottsdale Clinical Trials (Noah Clinical Site 017)
    Scottsdale, Arizona 85260, United States
  • Marvel Clinical Research (Noah Clinical Site 010)
    Huntington Beach, California 92647, United States
  • Accel Research Sites (Noah Clinical Site 019)
    DeLand, Florida 32720, United States
  • Health Awareness (Noah Clinical Site 020)
    Jupiter, Florida 33458, United States
  • Life Well Research Center (Noah Clinical Site 008)
    Miami, Florida 33134, United States
  • Regenerate Primary Medical Research (Noah Clinical Site 003)
    Miami, Florida 33134, United States
  • Miami Jewish Health (Noah Clinical Site 023)
    Miami, Florida 33137, United States
  • Neurology Associates of Ormond Beach (Noah Clinical Site 015)
    Ormond Beach, Florida 32174, United States
  • International Medical Investigational Centers (Noah Clinical Site 001)
    Palmetto Bay, Florida 33176, United States
  • Best Choice Medical and Research Service (Noah Clinical Site 025)
    Pembroke Pines, Florida 33024, United States
  • Denali Health Plant City, LLC (Noah Clinical Site 024)
    Plant City, Florida 33563, United States
  • Boston Clinical Trials (Noah Clinical Site 006)
    Boston, Massachusetts 02131, United States
  • IMA Clinical Research (Noah Clinical Site 004)
    Albuquerque, New Mexico 87109, United States
  • Carolina Research Center, Inc. (Noah Clinical Site 009)
    Shelby, North Carolina 28150, United States
  • Tekton Research (Noah Clinical Site 002)
    Yukon, Oklahoma 73099, United States
  • Olympus Clinical Research (Noah Clinical Site 014)
    Katy, Texas 77450, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2024 to primary completion in Nov 2025, 12 months.

Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's 12 months is below that.

Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2024
First posted
Sep 19, 2024
StartActual
Oct 16, 2024
Primary completionActual
Nov 5, 2025
CompletionActual
Dec 15, 2025
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06597058
Lead sponsor
Noah Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 16, 2024
Primary completion
Nov 5, 2025
Completion
Dec 15, 2025
Last update
Apr 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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