Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:12/7/2018
Start Date:October 2015
End Date:September 2017

Use our guide to learn which trials are right for you!

A Phase 3, Double-blind, Randomized Study of RVT-101 Versus Placebo When Added to Existing Stable Donepezil Treatment in Subjects With Mild to Moderate Alzheimer's Disease

This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an
adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.

This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101)
on both cognition and activities of daily living when added to stable donepezil treatment in
subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment.
This study will also provide further information on the safety and tolerability of the 35-mg
dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil
alone. This study is being conducted under the agreement of a Special Protocol Assessment by
FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study
of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's
disease including memantine will be allowed.

Inclusion Criteria:

- Male or female subject with AD

- Ongoing donepezil therapy for AD

- An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline

- Hachinski Ischaemia score less than or equal to 4 at Screening.

- If female, subject must be: a. of non-childbearing potential or surgically sterile;
or, b. willing to use an adequate methods of birth control. Male subjects who are
sexually active will also be required to use an adequate form of birth control.

- Subject has the ability to comply with procedures for cognitive and other testing in
the opinion of the investigator.

- Subject has a reliable caregiver who is willing to report on subject's status
throughout the study.

Exclusion Criteria:

Other Causes for Dementia

- Diagnosis of vascular dementia

- Atypical clinical features or clinical course of dementia that would lead the
investigator to conclude symptoms are more likely due to an alternate dementia
diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia,
or others.

Confounding Medical Conditions

- History of significant psychiatric illness such as schizophrenia or bipolar affective
disorder or any other significant psychiatric illness that in the opinion of the
investigator would interfere with participation in the study;

- Any clinically relevant concomitant disease, which, in the opinion of the
investigator, makes the subject unsuitable for inclusion in the study.
We found this trial at
62
sites
Charlotte, North Carolina 28270
2107
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Albany, New York 12208
2438
mi
from 91732
Albany, NY
Click here to add this to my saved trials
Atlanta, Georgia 30331
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30342
1918
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
Atlantis, Florida 33462
2305
mi
from 91732
Atlantis, FL
Click here to add this to my saved trials
Baton Rouge, Louisiana 70808
1584
mi
from 91732
Baton Rouge, LA
Click here to add this to my saved trials
Beachwood, Ohio 44122
2041
mi
from 91732
Beachwood, OH
Click here to add this to my saved trials
135 Berlin New Freedom Road
Berlin, New Jersey 08009
2388
mi
from 91732
Berlin, NJ
Click here to add this to my saved trials
Brooklyn, New York 11235
2436
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
Brooksville, Florida 34601
2126
mi
from 91732
Brooksville, FL
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
2208
mi
from 91732
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45227
1886
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
136 Ohio 3
Cincinnati, Ohio 45220
1879
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Georgia 31909
1903
mi
from 91732
Columbus, GA
Click here to add this to my saved trials
Encino, California 91436
28
mi
from 91732
Encino, CA
Click here to add this to my saved trials
Fullerton, California 92835
14
mi
from 91732
Fullerton, CA
Click here to add this to my saved trials
Hallandale Beach, Florida 33009
2318
mi
from 91732
Hallandale Beach, FL
Click here to add this to my saved trials
Hamden, Connecticut 06518
2487
mi
from 91732
Hamden, CT
Click here to add this to my saved trials
144 Mississippi Avenue
Hattiesburg, Mississippi 39401
1673
mi
from 91732
Hattiesburg, MS
Click here to add this to my saved trials
Hialeah, Florida 33012
2314
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77074
1351
mi
from 91732
Houston, TX
Click here to add this to my saved trials
130 Avenida La Plata
La Plata, Buenos Aires C1424
6111
mi
from 91732
La Plata,
Click here to add this to my saved trials
Las Vegas, Nevada 89113
207
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
197 Lawrenceville Road
Lawrenceville, New Jersey 08648
2396
mi
from 91732
Lawrenceville, NJ
Click here to add this to my saved trials
Los Angeles, California 90024
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Manchester, New Jersey 08759
2416
mi
from 91732
Manchester, NJ
Click here to add this to my saved trials
169 Penn Way
Media, Pennsylvania 19063
2363
mi
from 91732
Media, PA
Click here to add this to my saved trials
Miami, Florida 33137
2322
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33165
2322
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Mount Arlington, New Jersey 07856
2399
mi
from 91732
Mount Arlington, NJ
Click here to add this to my saved trials
New Hyde Park, New York 11040
2449
mi
from 91732
New Hyde Park, NY
Click here to add this to my saved trials
374 Temple Hill Road
New Windsor, New York 12553
2427
mi
from 91732
New Windsor, NY
Click here to add this to my saved trials
1 Bowling Green
New York, New York 10021
2432
mi
from 91732
New York, NY
Click here to add this to my saved trials
New York, New York 10022
2434
mi
from 91732
New York, NY
Click here to add this to my saved trials
Newton, Massachusetts 02459
2572
mi
from 91732
Newton, MA
Click here to add this to my saved trials
172 North Drive
North Palm Beach, Florida 33408
2300
mi
from 91732
North Palm Beach, FL
Click here to add this to my saved trials
Norwich, Connecticut 06360
2529
mi
from 91732
Norwich, CT
Click here to add this to my saved trials
Orem, Utah 84058
552
mi
from 91732
Orem, UT
Click here to add this to my saved trials
Orlando, Florida 32806
2184
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Pasadena, California 91105
9
mi
from 91732
Pasadena, CA
Click here to add this to my saved trials
Pensacola, Florida 32502
1810
mi
from 91732
Pensacola, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85005
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
162 North Pennsylvania Avenue
Plains, Pennsylvania 18075
2333
mi
from 91732
Plains, PA
Click here to add this to my saved trials
Portland, Oregon 97210
826
mi
from 91732
Portland, OR
Click here to add this to my saved trials
Quincy, Massachusetts 02169
2581
mi
from 91732
Quincy, MA
Click here to add this to my saved trials
Rancho Mirage, California 92270
94
mi
from 91732
Rancho Mirage, CA
Click here to add this to my saved trials
San Antonio, Texas 78229
1182
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
Santa Ana, California 92705
78
mi
from 91732
Santa Ana, CA
Click here to add this to my saved trials
Shaker Heights, Ohio 44122
2037
mi
from 91732
Shaker Heights, OH
Click here to add this to my saved trials
Shreveport, Louisiana 71104
1403
mi
from 91732
Shreveport, LA
Click here to add this to my saved trials
Simi Valley, California 93065
46
mi
from 91732
Simi Valley, CA
Click here to add this to my saved trials
Spokane, Washington 99202
939
mi
from 91732
Spokane, WA
Click here to add this to my saved trials
Tampa, Florida 33613
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Tampa, Florida 33613
2132
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Temecula, California 92591
63
mi
from 91732
Temecula, CA
Click here to add this to my saved trials
The Villages, Florida 32162
2142
mi
from 91732
The Villages, FL
Click here to add this to my saved trials
Toms River, New Jersey 08755
2425
mi
from 91732
Toms River, NJ
Click here to add this to my saved trials
Tucson, Arizona 85704
429
mi
from 91732
Tucson, AZ
Click here to add this to my saved trials
West Long Branch, New Jersey 07764
2434
mi
from 91732
West Long Branch, NJ
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19001
2202
mi
from 91732
Willow Grove, PA
Click here to add this to my saved trials