Alzheimer DiseaseNCT02854917
Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: Health Outcome
An observational study of Alzheimer Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
This study is a retrospective review of the data collected in a previously completed randomized, controlled trial (RCT) entitled "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" (NCT00120874). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 5 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study will only include data from previous participants in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study. In total, 20 participants completed the previous RCT and will have their data included in this retrospective study.
Who may be able to join
- Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial: Further Study, Health Outcome
This study is a retrospective review of the data collected in a previously completed randomized, controlled trial (RCT) entitled "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" (NCT00120874). As part of the previously completed RCT, participants with Alzheimer's Disease (AD) were randomly placed into one of two groups: memantine, or memantine plus an individualized management program consisting of home visits, educational sessions for caregivers, and a caregiver support group. Participants received the study intervention for 28 weeks; study follow-up lasted for 52 weeks.
The collected data from the existing study books from the 28 week treatment portion of the RCT will be carefully examined with respect to each of the research questions for the present retrospective study.
- Conditions
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Memantine Alone | 10 subjects who previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study will be enrolled in this cohort. These subjects received memantine for a period of 28 weeks. | |
| Memantine plus Individualized Management of AD | 10 subjects who previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study will be enrolled in this cohort. These subjects received memantine plus individualized management of AD for a period of 28 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of prescription medications taken throughout the study
Measured: 28 weeks
Total number of hospitalizations
Measured: 28 weeks
The total number of new medical conditions
Measured: 28 weeks
Total number of days of hospice care
Measured: 28 weeks
Secondary outcomes (15)
Total number of psychotropic medications used
Measured: 28 weeks
Total number of increases in psychotropic medications
Measured: 28 weeks
Total number of decreases in psychotropic medications
Measured: 28 weeks
Total number of cardiac medications taken during the study
Measured: 28 weeks
Total number arthritic and anti-inflammatory medications taken during the study
Measured: 28 weeks
Total number of analgesic medications taken during the study
Measured: 28 weeks
Total number of days hospitalized during the study
Measured: 28 weeks
Reasons for hospitalizations and hospital diagnoses during the study
This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
Measured: 28 weeks
Total number of tests and procedures performed during the hospitalizations
Measured: 28 weeks
Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization
The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.
The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)
Measured: 28 weeks
Time to death
Measured: 28 weeks
Cause of death
This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
Measured: 28 weeks
Caregiver training and support in relation to mortality
This endpoint will be examined qualitatively; no statistical analysis will be performed but the data will be compiled and reported for illustrative purposes
Measured: 28 weeks
Differences in rate of fecal incontinence
Measured: 28 weeks
Differences in rate of urinary incontinence
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion5 Jan 2018
- Study completion5 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories, Fisher Center for Alzheimer's Research Foundation
- Responsible party
- Sponsor
- Investigators
- Barry Reisberg, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854917
- Sponsor's protocol ID
- 12444
- Status last verified
- Jan 2018
- First submitted
- 1 Aug 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial: Further Study, Health Outcome
- ClinicalTrials.gov ID
- NCT02854917
- Acronym / sponsor ID
- 12444
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Forest Laboratories, Fisher Center for Alzheimer's Research Foundation
- Study start
- Jul 2016
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a retrospective review of the data collected in a previously completed randomized, controlled trial (RCT) entitled "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" (NCT00120874). As part of the previously completed RCT, participants with Alzheimer's Disease (AD) were randomly placed into one of two groups: memantine, or memantine plus an individualized management program consisting of home visits, educational sessions for caregivers, and a caregiver support group. Participants received the study intervention for 28 weeks; study follow-up lasted for 52 weeks.
The collected data from the existing study books from the 28 week treatment portion of the RCT will be carefully examined with respect to each of the research questions for the present retrospective study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine Alone | – | –10 subjects who previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study will be enrolled in this cohort. These subjects received memantine for a period of 28 weeks. |
| Memantine plus Individualized Management of AD | – | –10 subjects who previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study will be enrolled in this cohort. These subjects received memantine plus individualized management of AD for a period of 28 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study will only include data from previous participants in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study. In total, 20 participants completed the previous RCT and will have their data included in this retrospective study.
Key inclusion criteria (1 listed)
- Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total number of prescription medications taken throughout the study
Time frame: 28 weeks
Total number of hospitalizations
Time frame: 28 weeks
The total number of new medical conditions
Time frame: 28 weeks
Total number of days of hospice care
Time frame: 28 weeks
15 secondary outcomes
Total number of psychotropic medications used
Time frame: 28 weeks
Total number of increases in psychotropic medications
Time frame: 28 weeks
Total number of decreases in psychotropic medications
Time frame: 28 weeks
Total number of cardiac medications taken during the study
Time frame: 28 weeks
Total number arthritic and anti-inflammatory medications taken during the study
Time frame: 28 weeks
Total number of analgesic medications taken during the study
Time frame: 28 weeks
Total number of days hospitalized during the study
Time frame: 28 weeks
Reasons for hospitalizations and hospital diagnoses during the study
Time frame: 28 weeks
Total number of tests and procedures performed during the hospitalizations
Time frame: 28 weeks
Changes in Functional Assessment Staging Disability Score (FAST-DS) at subsequent study visits post hospitalization
Time frame: 28 weeks
Time to death
Time frame: 28 weeks
Cause of death
Time frame: 28 weeks
Caregiver training and support in relation to mortality
Time frame: 28 weeks
Differences in rate of fecal incontinence
Time frame: 28 weeks
Differences in rate of urinary incontinence
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- ClinicalTrials.gov record for the previously completed RCTLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Reisberg, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of prescription medications taken throughout the study (time frame: 28 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.