Clinical trial NCT06597058: Phase 2 Estimation Study of Fixed Dose Drugs Combination Type of Polypill
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Dementia
Neurodegeneration
Cognitive Impairments
Mental Deterioration
Loss of Memory
Lead sponsor: Noah Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 103
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 informed consent;
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. MMSE-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. Creatinine Clearance \&gt;30 mL/min at Screening;
13. Negative HIV and HCV 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 clinically significant as assessed by the Investigator at Screening;
15. Physical examination, vital signs, and ECG 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. Post-menopausal, 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 \&lt;12 months and FSH \&gt;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 contraception and refrain from donating sperm for the duration of their participation in the study and for 2 months thereafter.

Exclusion Criteria:

1. 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;
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 live vaccine during the study;
4. Current use of a cannabidiol or derivative;
5. Current use of digoxin;
6. Acute or chronic liver disease;
7. AST \&gt;1.5 times the Upper Limit of Normal
8. ALT \&gt; 1.5 times the Upper Limit of Normal
9. Schizophrenia, bipolar disorder, suicidal ideation, major depression, or delirium; Note: Stable (\&gt;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 investigational drug, device, or intervention within 30 days prior to the Screening Visit;

Primary outcomes:
measure: Clinical Dementia Rating - Global Score
timeFrame: Day 210
measure: Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
timeFrame: Day 210
measure: Mini-Mental Scale Evaluation, 2nd Edition (MMSE-2) Score
timeFrame: Day 210
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-COG)
timeFrame: Day 210
measure: Alzheimer's Disease Cooperative Study-ADL scale (ADCS-ADL)
timeFrame: Day 210
measure: Clinical Global Impressions - Improvement (CGI-I)
timeFrame: Day 210
measure: Clinical Global Impressions - Severity (CGI-S)
timeFrame: Day 210
measure: Clinical Dementia Rating - Global Score (Exploratory)
timeFrame: Day 210
measure: Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score (Exploratory)
timeFrame: Day 210
measure: Mini-Mental Scale Evaluation, 2nd Edition (MMSE-2) Score (Exploratory)
timeFrame: Day 210
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-COG) (Exploratory)
timeFrame: Day 210
measure: Alzheimer's Disease Cooperative Study-ADL scale (ADCS-ADL) (Exploratory)
timeFrame: Day 210
measure: Clinical Global Impressions - Improvement (CGI-I) (Exploratory)
timeFrame: Day 210
measure: Clinical Global Impressions - Severity (CGI-S) (Exploratory)
timeFrame: Day 210
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: Day 210
measure: Serious Adverse Events (SAEs)
timeFrame: Day 210
measure: Adverse Events (AEs)
timeFrame: Day 210
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials (Noah Clinical Site 017)
state: Arizona
city: Huntington Beach
country: United States
facility: Marvel Clinical Research (Noah Clinical Site 010)
state: California
city: DeLand
country: United States
facility: Accel Research Sites (Noah Clinical Site 019)
state: Florida
city: Jupiter
country: United States
facility: Health Awareness (Noah Clinical Site 020)
state: Florida
city: Miami
country: United States
facility: Life Well Research Center (Noah Clinical Site 008)
state: Florida
city: Miami
country: United States
facility: Regenerate Primary Medical Research (Noah Clinical Site 003)
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health (Noah Clinical Site 023)
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach (Noah Clinical Site 015)
state: Florida
city: Palmetto Bay
country: United States
facility: International Medical Investigational Centers (Noah Clinical Site 001)
state: Florida
city: Pembroke Pines
country: United States
facility: Best Choice Medical and Research Service (Noah Clinical Site 025)
state: Florida
city: Plant City
country: United States
facility: Denali Health Plant City, LLC (Noah Clinical Site 024)
state: Florida
city: Boston
country: United States
facility: Boston Clinical Trials (Noah Clinical Site 006)
state: Massachusetts
city: Albuquerque
country: United States
facility: IMA Clinical Research (Noah Clinical Site 004)
state: New Mexico
city: Shelby
country: United States
facility: Carolina Research Center, Inc. (Noah Clinical Site 009)
state: North Carolina
city: Yukon
country: United States
facility: Tekton Research (Noah Clinical Site 002)
state: Oklahoma
city: Katy
country: United States
facility: Olympus Clinical Research (Noah Clinical Site 014)
state: Texas
Study officials:
References: