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WAY

UnknownPhase 2

Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease

A Randomized, Double Blind, Placebo Controlled, Parallel-Group 52-week Multicenter Phase II Study to Investigate the Safety, Efficacy and Pharmacokinetics of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease

Asset

AD-35

Listed sites

1

Recruiting sites

-

Enrollment

240

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 15-26•MRI contraindications excluded

Primary endpoints

•ADAS-Cog•Changes in Alzheimer's Disease Cooperative Study-clinical global impression

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

Org study IDAD-35-II-01
NCT IDNCT03790982

Timeline

Milestones

Study start2018-12-01actual
Study first posted2019-01-02actual
Last update posted2019-01-02actual
Primary completion2020-12-30estimated
Study completion2021-07-30estimated

Assets

Drug assets

AD-35

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Men and women, 50-75 years of age.
•Formal education of five or more years.
•Diagnosed of probable AD in accordance with the NINCDS/ADRDA criteria (2011).
•Mild or moderate AD subjects: MMSE Score of 15-26 and CDR Score ≥ 0.5 (CDR memory score ≥ 0.5).
•Subjects must have a brain magnetic resonance imaging (MRI) scan that is consistent with a clinical diagnosis of probable AD. Brain atrophy and medial temporal lobe atrophy visual assessment scale MTA grading >2 points. Mild white matter degeneration may occur, but Fazekas less than or equal to 2 points and supratentorial lacunar infarction lesions less than or equal to 3 points.
•The total score of modified Hachinski ischemia scale (MHIS) ≤ 4.
•Hamilton depression scale (HAMD) has a total score ≤ 17

Exclusion criteria

•Visual, hearing and verbal communication of subjects cannot meet the needs of cognitive function evaluation.
•Inability to tolerate MRI procedures or contraindication to MRI, (such as implanted in the body, MRI incompatible pacemakers, implantable cardioverter defibrillators, cochlear implants, aneurysm clips, implanted injection pump, implanted nerve stimulator, metallic splinters in the eye, other magnetic, electrical and other metal implants) [note], or any other situation, in the judgment of the Investigator, is not suitable for magnetic resonance imaging (MRI).
•The investigators believe that other severe or unstable conditions may interfere with the cognitive evaluation in clinical trials.
•Dementia caused by other reasons: vascular dementia, central nervous system infection, endocrine system diseases (such as thyroid disease, parathyroid gland disease) and other reasons.

Endpoints (5)

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
2
Other (unclassified)
2
Other clinical outcomes
1

Global cognition

2 endpoints
Primary/protocol endpoint

Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11 scores

Time frame:Week 26

ADAS-Cog

descriptive

Other/protocol endpoint

Changes in Mini-mental state examination (MMSE) scores

Time frame:Week 6, week 13, week 26, week 39, week52

Mini-Mental State Examination (MMSE)

descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Changes in Alzheimer's Disease Cooperative Study-clinical global impression of change (ADCS-CGIC ) scores

Time frame:Week 26

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Changes in ADAS-Cog11 scores

Time frame:Week 6, week 13, week 39, week52

ADAS-Cog

descriptive

Other/protocol endpoint/low confidence

Changes in ADCS-CGIC scores

Time frame:Week 6, week 13, week 39, week52

descriptive

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.