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Alzheimer DiseasePhase 2NCT06597058

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

A Phase 2 study testing MAR in people with Alzheimer Disease, run by Noah Pharmaceuticals, Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
MAR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
16 sitesUnited States
Study dates
16 Oct 2024to 15 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • 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;
  • Male or female, age 50 to 85 years (inclusive) at the Screening Visit;
  • 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 informed consent;
  • 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);
  • Body weight at screening is ≥40kg;
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  • CDR-SB of 3.0 or higher at Screening Visit;
  • MMSE-2 ≥8 and≤24 at the Screening Visit;
  • 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);
  • 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;
  • Patients currently treated with a statin must agree to stop their statin therapy for the duration of treatment (180 days);
  • Creatinine Clearance \>30 mL/min at Screening;
  • Negative HIV and HCV test at Screening;
  • Complete blood count (CBC), blood chemistry, serum cholesterol, triglycerides, thyroid-stimulating hormone (TSH), and urinalysis, within normal reference ranges or not clinically significant as assessed by the Investigator at Screening;
  • Physical examination, vital signs, and ECG within normal ranges or not clinically significant as assessed by the Investigator at Screening;
  • Female patients may participate if they meet 1 of the following criteria:
  • Surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or
  • Post-menopausal, defined as
  • Permanent cessation of menstruation for ≥12 months without an alternative medical cause (regardless of follicle-stimulating hormone [FSH] value) at the Screening Visit, or
  • 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.
  • Male patients must agree to use a barrier method of contraception and refrain from donating sperm for the duration of their participation in the study and for 2 months thereafter.

Who cannot join

  • Patient has had a myocardial infarction, unstable angina, stroke, transient ischemic attack 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;
  • 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;
  • Scheduled or anticipates vaccination with a live vaccine during the study;
  • Current use of a cannabidiol or derivative;
  • Current use of digoxin;
  • Acute or chronic liver disease;
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  • AST \>1.5 times the Upper Limit of Normal
  • ALT \> 1.5 times the Upper Limit of Normal
  • Schizophrenia, bipolar disorder, suicidal ideation, major depression, or delirium; Note: Stable (\>2 years) treated depression without suicidal ideation is acceptable;
  • Current therapy with a tetracycline;
  • Current therapy with sirolimus or a rapalog macrolide antibiotic;
  • Known allergies to any of the active drugs: tetracycline antibiotics, rapalog macrolide antibiotics, or statin therapies;
  • Treatment with another investigational drug, device, or intervention within 30 days prior to the Screening Visit;

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • IMA Clinical Research (Noah Clinical Site 004)

    Albuquerque, New Mexico, 87109

  • Boston Clinical Trials (Noah Clinical Site 006)

    Boston, Massachusetts, 02131

  • Accel Research Sites (Noah Clinical Site 019)

    DeLand, Florida, 32720

  • Marvel Clinical Research (Noah Clinical Site 010)

    Huntington Beach, California, 92647

  • Health Awareness (Noah Clinical Site 020)

    Jupiter, Florida, 33458

  • Olympus Clinical Research (Noah Clinical Site 014)

    Katy, Texas, 77450

  • Life Well Research Center (Noah Clinical Site 008)

    Miami, Florida, 33134

  • Regenerate Primary Medical Research (Noah Clinical Site 003)

    Miami, Florida, 33134

  • Miami Jewish Health (Noah Clinical Site 023)

    Miami, Florida, 33137

  • Neurology Associates of Ormond Beach (Noah Clinical Site 015)

    Ormond Beach, Florida, 32174

  • International Medical Investigational Centers (Noah Clinical Site 001)

    Palmetto Bay, Florida, 33176

  • Best Choice Medical and Research Service (Noah Clinical Site 025)

    Pembroke Pines, Florida, 33024

  • Denali Health Plant City, LLC (Noah Clinical Site 024)

    Plant City, Florida, 33563

  • Scottsdale Clinical Trials (Noah Clinical Site 017)

    Scottsdale, Arizona, 85260

  • Carolina Research Center, Inc. (Noah Clinical Site 009)

    Shelby, North Carolina, 28150

  • Tekton Research (Noah Clinical Site 002)

    Yukon, Oklahoma, 73099

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled Phase 2 Estimation Study of Fixed Dose Drugs Combination Type of Polypill Administered to Subjects With Alzheimer's Disease

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.

Being tested
MAR
Keywords
Dementia, Neurodegeneration, Cognitive Impairments, Mental Deterioration, Loss of Memory
Medical subject headings
Alzheimer Disease, Dementia, Nerve Degeneration, Cognitive Dysfunction, Amnesia

What participants receive

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

  • MARDrug

    Once-daily tablet

Study groups in NCT06597058
Study groupRoleWhat they receive
MAR COMBOExperimentalMAR Active 0.6 g, Tablet, once-daily, 180 days
Receives: Drug: MAR
MAR PLACEBOPlacebo comparatorMAR Placebo 0.6 g, Tablet, once-daily, 180 days
Receives: Drug: MAR

What is being measured

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

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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".

    Measured: 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.

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: Day 210

  15. Treatment-emergent adverse events (TEAEs)

    Incidence of TEAEs through Day 210

    Measured: Day 210

  16. Serious Adverse Events (SAEs)

    Incidence of SAEs from informed consent through Day 210

    Measured: Day 210

  17. Adverse Events (AEs)

    Incidence of AEs from informed consent through Day 210

    Measured: Day 210

Timeline

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

  1. First posted19 Sep 2024
  2. Study start16 Oct 2024
  3. Primary completion5 Nov 2025
  4. Study completion15 Dec 2025

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06597058
Sponsor's protocol ID
T000439
Status last verified
Apr 2026
First submitted
11 Sep 2024
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MAR in people with Alzheimer Disease, run by Noah Pharmaceuticals, Inc. at 16 sites 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 22 inclusion and 13 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: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Dementia Rating - Global Score (time frame: Day 210). The study lists 17 primary outcomes in all. 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 NCT06597058.

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 8 Apr 2026.

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Clinical Trial NCT06597058 | AzTrials