DOPAD

CompletedPhase 2

Effects of Dopaminergic Therapy in Patients With Alzheimer's Disease

Effects of Dopaminergic Therapy in Patients With Alzheimer's Disease: a Phase II 24-week, Randomized, Double-blind Placebo Controlled Study.

Lead sponsor

I.R.C.C.S. Fondazione Santa Lucia

Asset

Rotigotine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20-26•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

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 IDEudraCT 2015-002965-43

NCT IDNCT03250741

Timeline

Milestones

Study start2016-06actual (month precision)

Study first posted2017-08-16actual

Primary completion2018-11actual (month precision)

Study completion2018-11actual (month precision)

Last update posted2018-12-17actual

Assets

Drug assets

Rotigotine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. The patient (or if applicable the legally acceptable representative if different from the responsible caregiver) and the responsible caregiver have signed the Informed Consent Form.

2. The patient has probable AD, diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.

3. The patient is a man or woman, aged ≤ 85 years.

4. The patient has a Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild) and MMSE score of 20-26 (inclusive) at Screening.

5. Has at least one identified adult caregiver who is able to provide meaningful assessment of changes in subject behavior and function over time and provide information on safety and tolerability, and is able to verify daily compliance with study drug

6. The patient has been treated with acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, at the time of Screening

-For at least 3 months

-The current dosage regimen and must have remained stable for ≥ 8 weeks

-It must be planned that the dosage regimen will remain stable throughout participation in the study

Exclusion criteria

1. Significant neurodegenerative disorder of the central nervous system other than Alzheimer's disease, e.g., Lewy body dementia, Parkinson's disease, multiple sclerosis, progressive supranuclear palsy, hydrocephalus, Huntington's disease, any condition directly or indirectly caused by Transmissible Spongiform Encephalopathy (TSE), Creutzfeldt-Jakob Disease (CJD), variant Creutzfeldt-Jakob Disease (vCJD), or new variant Creutzfeldt-Jakob Disease (nvCJD)

2. The patients has history of seizure (with the exception of febrile seizures in childhood)

3. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM IV-TR) criteria met for any of the following within specified period:

-Major depressive disorder (current)

-Schizophrenia (lifetime)

-Other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders (within the past 5 years)

4. Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging.

5. Evidence of clinically significant disease including but not limited to pulmonary, gastrointestinal, renal, hepatic, endocrine, cardiovascular or metabolic disorder (Patients with controlled diabetes, or hypertension, or complete/partial right bundle branch block may be included in the study).

6. Treatment currently or within 6 months before Baseline with any of the following medications:

-Typical and atypical antipsychotics (i.e. Clozapine, Olanzapine)

-Antiparkinson agents (e.g., levodopa, dopamine agonists, COMT inhibitors, amantadine, monoamine oxidase B inhibitors, anticholinergics etc)

-Carbamazepine, Primidone, Pregabalin, Gabapentin

-Memantine

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

Executive function / language

Function / daily living

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

1 endpoint

Primary/protocol endpoint

Global cognition

Time frame:change from baseline to Week 24

ADAS-Cog

descriptive

Executive function / language

1 endpoint

Secondary/protocol endpoint

Frontal cognitive functions

Time frame:change from baseline to Week 24

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Activities of daily living

Time frame:change from baseline to Week 24

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Neuropsychiatric evaluation

Time frame:change from baseline to Week 24

Neuropsychiatric Inventory (NPI)

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Neurophysiological markers of cortical activity

Time frame:change from baseline to Week 24

descriptive

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.