NCT02359552

Brief Summary

This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of concept three-site study, to evaluate the effect of Rasagiline in the regional brain metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2015

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

3.3 years

First QC Date

February 5, 2015

Results QC Date

January 6, 2020

Last Update Submit

October 21, 2020

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • 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).

    The primary outcome measure is the change from baseline to week 24 in FDG-PET as measured by Standard Uptake Units Regional (SUVR) in several pre-specified brain regions including the medial temporal, lateral temporal, posterior cingulate - precuneus, inferior parietal, middle frontal, anterior cingulate, and striatum. The SUVR change was calculated by subtracting the value at 24 weeks from baseline values. Negative values indicate increased hypometabolism (i.e. worsening of cell function).

    24 weeks

Secondary Outcomes (7)

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

    Mean change in scores from baseline to week 24

  • Change in MMSE (Mini Mental Status Examination) Score

    Mean change in scores from baseline to week 24

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

    Mean change in scores from baseline to week 24

  • Change in NPI (Neuropsychiatric Inventory) Score

    Mean change in scores from baseline to week 24

  • Change in Digit Span

    Mean change in scores from baseline to week 24

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment. Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).

Drug: Placebo

Rasagiline

ACTIVE COMPARATOR

Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment. Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).

Drug: Rasagiline

Interventions

RasagilineDRUG
Rasagiline
PlaceboDRUG
Placebo

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic Lakewood Hospital

Lakewood, Ohio, 44107, United States

Location

Related Publications (4)

  • Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.

    PMID: 6496779BACKGROUND

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND

  • Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9.

    PMID: 9236950BACKGROUND

  • Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.

    PMID: 9153155BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Aaron Ritter
Organization
Cleveland Clinic Lou Ruvo Center for Brain Health
rittera@ccf.org
702-483-6049

Study Officials

  • Jeffrey L Cummings, MD, ScD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 10, 2015

Study Start

May 1, 2015

Primary Completion

August 29, 2018

Study Completion

January 4, 2019

Last Updated

November 10, 2020

Results First Posted

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)