CompletedPhase 2

A Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease

A 6-Month, Double-Blind, Phase 2 Study and 6-Month Open- Label Extension Evaluating the Safety, Tolerability, and Clinical Benefit of RPh201 in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease

Lead sponsor

Regenera Pharma Ltd

Asset

RPh201

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 15-22•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Clinical Dementia Rating-Sum of Boxes (CDR-SB)•AEs

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03462121

Org study IDRGN-ADC-002

Timeline

Milestones

Study start2018-03-01actual

Study first posted2018-03-12actual

Primary completion2019-12-28actual

Study completion2020-03-30actual

Last update posted2020-04-30actual

Assets

Drug assets

RPh201

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects must be ≥65 years of age at the time of consent.

•Subjects 65-69 years old, inclusive, must have evidence of cerebrovascular disease.

•Meet National Institute on Aging-Alzheimer's Association 2011 criteria for All-Cause Dementia and have evidence for probable AD or possible AD with coexisting cerebrovascular disease. Coexisting cerebrovascular disease includes evidence of any of the following: cortical infarcts, subcortical and lacunar infarcts, macro or micro-hemorrhage, and small vessel ischemic microangiopathy.

•Willing and able to provide informed consent or, if incapable of informed consent, have a legally authorized representative willing to consent on their behalf.

•MMSE at screen visit: 15-22, inclusive.

•Cholinesterase inhibitors, memantine, and other background medications impacting cognition and mood, if used, are at stable doses for at least 6 weeks prior to screening.

•A study partner is available who has adequate contact with the subject to administer study drug, oversee study drug compliance, report on adverse events (AEs), and provide meaningful input into scales and assessments.

•Adequate hearing, vision, and fluency in the language of testing.

•Magnetic resonance imaging (MRI) of the brain must reveal findings consistent with AD with or without coexisting cerebrovascular disease. In subjects for whom brain MRI is contraindicated (e.g., presence of a pacemaker), computed tomography (CT) of the brain is acceptable. Historic MRI or CT scans up to 18 months prior to screening may be used for inclusion unless there have been interval clinical events warranting an updated scan.

•Male subjects who are sexually active must agree to use one of the following acceptable methods of birth control from Screening and for at least one month after the last dose of study drug: abstinence (no sexual intercourse), male condom, or vasectomy.

•Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

•Optional FDG-PET sub-study: no contraindications to PET imaging. Individuals participating in the FDG-PET sub-study will be capped at 15 volunteers and a further cap may be imposed on the number enrolling in this sub-study without evidence of cerebrovascular disease

Exclusion criteria

•Neurological or non-neurological conditions other than AD and cerebrovascular disease that, in the Investigator's opinion, contribute to, or provide alternative etiology for, the subject's dementia. Examples include, but are not limited to, brain tumors, clinically significant head injury, Parkinson's disease, current or prior excess use of alcohol that, in the investigator's judgment, has caused or significantly contributed to the subject's cognitive decline, or primary psychiatric disorders (e.g., schizophrenia or bipolar affective disorder).

•Unstable medical conditions which are likely to impact subject's ability to complete the trial and which are likely to confound AE assessment. These include, but are not limited to, uncontrolled hypertension, uncontrolled diabetes, and cancer within past the 2 years. Exceptions include prostate cancer in-situ and local basal and squamous cell skin cancers.

•Chronic use of systemic or inhaled steroids (use of topical steroids is acceptable).

•Other concomitant medications that, in the Investigator's judgment, impair cognition and/or confound efficacy assessments.

•Women of child-bearing potential are excluded (e.g., women who have not been post-menopausal for at least 2 years or are not surgically sterile).

•Treatment with investigational product from a previous clinical drug trial within the last 30 days or five half-lives prior to Visit 2 (Baseline), whichever is longer.

Endpoints (28)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Behavior / neuropsychiatric

Safety / tolerability / PK

Function / daily living

Neuroimaging

Global cognition

11 endpoints

Primary/protocol endpoint

Change in (Alzheimer disease assessment scale) ADAS-Cog score between Baseline and Month 6

Time frame:Month 6

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change in CDR-SB score between Baseline and Month 6

Time frame:Month 6

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline on ADAS-Cog total scores at Month 3

Time frame:Months 3

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline on ADAS-Cog total scores at Month 5

Time frame:Month 5

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline on ADAS-Cog total scores at Month 12

Time frame:Month 12

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline on CDR-SB total scores at Month 3

Time frame:Month 3

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline on CDR-SB total scores at Month 5

Time frame:Month 5

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline on CDR-SB total scores at Month 12

Time frame:Month 12

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the MMSE at Month 3

Time frame:Month 3

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the MMSE at Month 6

Time frame:Month 6

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the MMSE at Month 12

Time frame:Month 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change from Baseline in ADCS-ADL total score at Month 3

Time frame:Month 3

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in ADCS-ADL total score at Months 12

Time frame:Month 12

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

3 endpoints

Secondary/protocol endpoint

Change from Baseline in NPI total score at Month 3

Time frame:Month 3

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in NPI total score at Month 6

Time frame:Month 6

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in NPI total score at Month 12

Time frame:Month 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Neuroimaging

1 endpoint

Other/protocol endpoint

Change in FDG-PET between Baseline and Month 6 in a subset of subjects (Optinal)

Time frame:Month 6

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Vital Signs

Time frame:Month 6

descriptive

Secondary/protocol endpoint

Clinically significant changes in vital signs at Month 12

Time frame:Month 12

descriptive

Secondary/protocol endpoint

Vital Signs

Time frame:Month 12

descriptive

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

AEs at Month 6

Time frame:Month 6

descriptive

Primary/protocol endpoint/low confidence

12-lead ECG at Month 6

Time frame:Month 6

descriptive

Primary/protocol endpoint/low confidence

Clinical Laboratory Assessments - (blood and urine) at at Month 6

Time frame:Month 6

descriptive

Secondary/protocol endpoint/low confidence

AEs at Month 12

Time frame:Month 12

descriptive

Secondary/protocol endpoint/low confidence

12-lead ECG at Month 12

Time frame:Month 12

descriptive

Secondary/protocol endpoint/low confidence

Clinical Laboratory Assessments - (blood and urine) at Month 12

Time frame:Month 12

descriptive

Other/protocol endpoint/low confidence

AD blood biomarkers to assess change from Baseline at Month 6

Time frame:Month 6

change from baseline, improvement

Other/protocol endpoint/low confidence

AD blood biomarkers to assess change from Baseline at Month 12

Time frame:Month 12

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.