CompletedPhase 2Results posted

Rasagiline Rescue in Alzheimer's Disease Clinical Trial

A 24-week, Three-site, Randomized, Double Blind, Placebo Controlled, Parallel Group, Proof-of-concept Study to Evaluate Rasagiline in the Regional Brain Metabolism on FDG PET in Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

The Cleveland Clinic

Asset

Rasagiline

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Regional Glucose Metabolism Between Week 24 and Baseline

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 ID14-519

NCT IDNCT02359552

Timeline

Milestones

Study first posted2015-02-10estimated

Study start2015-05actual (month precision)

Primary completion2018-08-29actual

Study completion2019-01-04actual

Results first posted2020-10-20actual

Last update posted2020-11-10actual

Assets

Drug assets

Rasagiline

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Males or females 50 to 90 of age inclusive.

•Diagnosis of probable AD (NINCDS-ADRDA criteria)

•Positive fluoro-deoxyglucose PET ([18F]-FDG PET) scan compatible with AD as determined by the ADM Diagnostics LLC (ADMdx) Criteria at screening

•Mini Mental Status Exam = 12 - 22 (inclusive)

•Must have a study partner who is able and willing to comply with all required study procedures.

•Have at least eight years of education and should have previously (in pre-AD condition) been capable of reading, writing, and communicating effectively with others in English.

•If receiving therapy with a cholinesterase inhibitor and/or memantine, the dose of these agents has been stable for at least 3 months prior to screening

Exclusion criteria

•Any non-AD neurological disease

•MRI findings indication of a non-AD diagnosis

•Screening laboratory studies that are 1.5 times above or below the highest and lowest range of normal for each test respectively

•History of melanoma; history of malignancy within the past five years with the exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized prostate cancer

Endpoints (16)

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

Neuroimaging

Caregiver / quality of life

Other (unclassified)

Global cognition

4 endpoints

Secondary/protocol endpoint

Change in ADAS-Cog 11 (Alzheimer's Disease Assessment Scale - Cognitive 11) Score

Time frame:Mean change in scores from baseline to week 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in MMSE (Mini Mental Status Examination) Score

Time frame:Mean change in scores from baseline to week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change in ADAS-Cog 11 (Alzheimer's Disease Assessment Scale - Cognitive 11) Score

Time frame:Mean change in scores from baseline to week 24

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=25 Participants	2.76	4.3
Rasagilinen=25 Participants	1.81	4.43

Secondary/registry result

Change in MMSE (Mini Mental Status Examination) Score

Time frame:Mean change in scores from baseline to week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=25 Participants	-1.14	2.27
Rasagilinen=25 Participants	-0.65	2.48

Executive function / language

2 endpoints

Secondary/protocol endpoint

Change in COWAT (Controlled Oral Word Association Test) Score

Time frame:Mean change in scores from baseline to week 24

change from baseline, improvement

Secondary/registry result

Change in COWAT (Controlled Oral Word Association Test) Score

Time frame:Mean change in scores from baseline to week 24

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=25 Participants	-1.09	6.31
Rasagilinen=25 Participants	0.62	5.55

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) Score

Time frame:Mean change in scores from baseline to week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) Score

Time frame:Mean change in scores from baseline to week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=25 Participants	-3.23	6.71
Rasagilinen=25 Participants	-3.75	7.27

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change in NPI (Neuropsychiatric Inventory) Score

Time frame:Mean change in scores from baseline to week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change in NPI (Neuropsychiatric Inventory) Score

Time frame:Mean change in scores from baseline to week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=25 Participants	2	7.18
Rasagilinen=25 Participants	0.2	6.79

Neuroimaging

2 endpoints

Primary/protocol endpoint

Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).

Time frame:24 weeks

change from baseline, improvement

Primary/registry result

Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).

Time frame:24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), SUVR	Standard deviation
PlaceboMiddle Frontaln=25 Participants	-0.032	0.030
Anterior Cingulaten=25 Participants	-0.020	0.021
Superior Frontaln=25 Participants	-0.016	0.022
Striatumn=25 Participants	-0.024	0.029
Medial Temporaln=25 Participants	-0.015	0.034
Lateral Temporaln=25 Participants	-0.020	0.029
Post Cingulate - Precuneusn=25 Participants	-0.017	0.023
Inferior Parietaln=25 Participants	-0.025	0.029
RasagilineMiddle Frontaln=25 Participants	-0.011	0.030
Anterior Cingulaten=25 Participants	-0.003	0.026
Superior Frontaln=25 Participants	-0.003	0.018
Striatumn=25 Participants	-0.002	0.028
Medial Temporaln=25 Participants	-0.010	0.034
Lateral Temporaln=25 Participants	-0.016	0.024
Post Cingulate - Precuneusn=25 Participants	-0.016	0.018
Inferior Parietaln=25 Participants	-0.018	0.022

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Change in QoL-AD (Quality of Life - Alzheimer's Disease) Score

Time frame:This assessment will be performed at the Baseline and Week 24 visits.

change from baseline, improvement

Secondary/registry result

Change in QoL-AD (Quality of Life - Alzheimer's Disease) Score

Time frame:This assessment will be performed at the Baseline and Week 24 visits.

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=25 Participants	-1.95	3.28
Rasagilinen=25 Participants	1.11	3.77

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in Digit Span

Time frame:Mean change in scores from baseline to week 24

change from baseline, improvement

Secondary/registry result/low confidence

Change in Digit Span

Time frame:Mean change in scores from baseline to week 24

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=25 Participants	-1.18	1.92
Rasagilinen=25 Participants	-0.29	3.08

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 tableClinicalTrials.gov results section

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.