APA-AD

CompletedPhase 3

Bupropion for the Treatment of Apathy in Alzheimer's Dementia

A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Bupropion for the Treatment of Apathy in Alzheimer's Dementia(Apa-AD)

Lead sponsor

University Hospital, Bonn

Asset

Elontril

Listed sites

Recruiting sites

Enrollment

110

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD / moderate AD dementia•MMSE 10-25•Study partner/caregiver required

Primary endpoint

•Apathy Evaluation Scale (AES) score

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 ID2007-005352-17

NCT IDNCT01047254

Timeline

Milestones

Study start2010-01 (month precision)

Study first posted2010-01-12estimated

Primary completion2014-07actual (month precision)

Study completion2014-07actual (month precision)

Last update posted2017-05-09actual

Assets

Drug assets

Elontril

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Mild to moderate Alzheimer's dementia, male and female (NINCDS/ADRDA criteria)

•Presence of clinically relevant apathy defined by the Neuropsychiatric Inventory (NPI) apathy item (score of >/= 4 points) and the Marin/Starkstein criteria for apathy

•MMSE: 10-25

•Outpatient status, not institutionalized

•Presence of reliable caregiver

•Stable treatment with antidementia drugs for at least three months prior to entry or no treatment with antidementia drugs

Exclusion criteria

•Other Dementia (e.g. vascular dementia, Lewy-body dementia, fronto-temporal dementia)

•Presence of a clinically relevant depression defined by either the NPI depression item (score >/= 4 points) or DSM-IV criteria for major depressive episode (with depressed mood)

•Alcoholism and Benzodiazepine addiction

•Current treatment with antipsychotics and antidepressants (including St. John's wart)

•Current treatment with dopaminergic agents or Amantadin

•Current treatment with benzodiazepines

•Current treatment with MAO inhibitor (Bupropion contraindication)

•Known sensibility to Bupropion treatment

•Severe psychiatric disease (including hospitalization) in the last 6 months, suicide attempt, acute psychotic symptoms

•Severe physical illness, that do not allow a participation in a 12-week period of treatment

•Medical history with seizures

•Medical history with tumors of the central nervous system

•Severe craniocerebral injury and medical history with cerebral substance defect

•Clinically relevant renal disease, liver insufficiency

•Simultaneous treatment, which reduces the seizure threshold (e.g. antipsychotics, antidepressants, antimalarial agents, Tramadol, Theophyllin, systemic steroids in higher dose, Chinolone, sedative antihistamines)

•Simultaneous treatment, which is metabolized through Cytochrom P450-Isoenzym 2D6 (e.g. these beta blockers: Metoprolol, Proanolol, Timolol, Carvediol, Nebivolol, Typ-1C-Antiarrhyhtmics for e.g. Propafenon, Flecinid) (except Donepezil and Galantamin)

•Simultaneous treatment with drugs, which may interfere with the metabolization of Bupropion (e.g. Carbamazepin, Phenytoin, Valproat, Ritonavir, Lopinavir)

•Diabetes mellitus, which is therapeutically poorly regulated and treated by medication

•Treatment with stimulants and appetite depressants

•Participation in other clinical trials with in the last 3 months

•Suicidal tendency

•Known lactose intolerance

Endpoints (2)

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

Behavior / neuropsychiatric

Global cognition

1 endpoint

Secondary/protocol endpoint

NPI total score;NPI caregivers' distress total score;ADCS-ADL; QoL-AD; RUD;ADAScog;MMSE

Time frame:12 weeks

ADAS-Cog

descriptive

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Change in Apathy Evaluation Scale (AES) score

Time frame:12 weeks

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.