Back to resultsMemantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
Primary Purpose
Frontal Lobe Dementia, Frontotemporal Lobe Dementia, Semantic Dementia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
memantine
Placebo pill
Sponsored by
About this trial
This is an interventional treatment trial for Frontal Lobe Dementia focused on measuring Randomized, Double-Blind, Placebo-Controlled, memantine, Namenda, Frontotemporal Dementia, Semantic Dementia, FTD, SD, dementia, behavioral decline, cognitive decline
Eligibility Criteria
Inclusion Criteria:
A subject must meet ALL of the following criteria to be considered for enrollment in this study:
- Signed and dated written informed consent obtained from the subject and the subject's caregiver in accordance with local IRB regulations.
- Must meet criteria Neary et al. criteria for frontotemporal dementia (FTD) or semantic dementia (SD)
- Age: 40-80
- CT or MRI of brain within 12 months consistent with a diagnosis of FTD or SD.
- MMSE ≥ 15 at screening visit.
- Judged by investigator to be able to comply with neuropsychological evaluation at baseline.
- Must have reliable caregiver accompany subject to all study visits. Caregiver must read, understand and speak English fluently in order to ensure comprehension of informed consent form and informant-based assessments of subject. Caregiver must also have frequent contact with subject (at least 3 times per week for one hour) and be willing to monitor study medication compliance and the subject's health and concomitant medications throughout the study.
- In the opinion of the investigator, the patient and the caregiver will be compliant with the protocol and have a high probability of completing the study.
Exclusion Criteria:
Any one of the following will exclude a subject from being enrolled into the study:
- Insufficient fluency in English to complete neuropsychological and functional assessments.
- Concurrent Motor Neuron Disease judged by investigator to have bulbar or upper extremity impairments at baseline that would interfere with neuropsychological assessment, or that are expected to lead to such impairments within one month.
- Exclusion criteria as listed in Neary criteria. Diagnosis of progressive nonfluent aphasia by Neary criteria.
- Use of memantine within 4 weeks prior to randomization.
- Evidence of other neurological or psychiatric disorders which preclude diagnosis of FTD (including, but not limited to, stroke, Parkinson's disease, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, or head injury with loss of consciousness) within the past year.
- Concurrent treatment with acetylcholinesterase inhibitors, antipsychotic agents, mood stabilizers (valproate or lithium) or benzodiazepines (other than temazepam or zolpidem), or use of any of these agents within 4 weeks prior to randomization. Atypical antipsychotic agents may be started after the baseline visit if felt to be medically necessary by the investigator and will be recorded as a secondary outcome measure.
- History of alcohol or substance abuse within 1 year prior to screening, if deemed clinically significant by investigator.
- Any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
- Clinically significant lab abnormalities at screening, including Creatinine ≥ 1.7, B12 below laboratory normal reference range or TSH above site's laboratory normal reference range. Subjects with abnormal B12 or TSH levels at screening may be included per investigator's discretion.
9. CT or MRI evidence of any of the following: hydrocephalus, stroke, space-occupying lesion, cerebral infection or any clinically significant CNS disease other than FTD.
10.Systolic blood pressure greater than 180 or less than 90 mm Hg. Diastolic blood pressure greater than 105 or less than 50 mm Hg.
11. Abnormal ECG at screening judged to be clinically significant by the investigator.
12. Use of investigational drugs or participation in investigational drug study within 60 days of screening.
Sites / Locations
- University of California, Los Angeles
- University California, San Francisco
- Mayo Clinic - Jacksonville
- Northwestern University
- Johns Hopkins Hospital
- Mayo Clinic - Rochester
- University of North Carolina at Chapel Hill
- University Hospitals of Cleveland / Case Medical Center
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Memantine 10mg BID
Placebo condition
Outcomes
Primary Outcome Measures
Change in Neuropsychiatric Inventory (NPI)
NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions indicate that the patient has problems with a particular sub-domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequency of the symptoms on a 4-point scale, their severity on a 3-point scale, and the distress the symptom causes them on a 5-point scale. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.
Clinical Global Impression of Change (CGIC)
The scale is rated on a 7-point scale, using a range of responses from 1 (very much improved) through 7 (very much worse). The clinician compares the participant's current condition to the condition at admission to the project.
Secondary Outcome Measures
Longitudinal Changes From Baseline to 26 Weeks for Test Battery: CDR-SB, FAQ, TFLS, MMSE, EXIT25, UPDRS, Boston Naming Test
Clinical dementia rating sum of boxes CDR-SB (0-18) high scores indicate high impairment.
Functional activities questionnaire FAQ (0-30) high scores indicate high impairment.
Texas functional living scale TFLS (0 to 52) high scores suggest better instrumental activities of daily living functioning.
Mini-Mental State Examination MMSE (0-30) low scores indicate low cognition. The executive interview EXIT25 (0 to 50) high scores indicate more executive impairment.
A modified unified Parkinson's disease rating scale UPDRS (0-199) high scores indicate worse disability.
Boston naming test (0-15) low scores indicate more retrieval difficulties.
Longitudinal Changes From Baseline to 26 Weeks for Test Battery: Letter Fluency, Category Fluency, Digit Symbol, Digits Backwards
Letter fluency, score is number of words recalled starting with a specified letter for 60 seconds. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials for the score. Low scores indicate high impairment
Category fluency, score is number of items generated belonging to a specific category (such as animals) in 60 seconds, low scores indicate high impairment.
Digit symbol, score is number of symbols that correctly corresponded to the random numerals entered in the form in 90 seconds. Participants are given a table of numerals with matching symbols, and a form with random numerals with open spaces. Low scores indicate high impairment.
Digits backwards, score is number of digits backwards recalled (range: 0-14), The participant hears a list of digits and is asked to repeat the digits backwards. Low scores indicate high impairment.
Number of Participants Starting Antipsychotic Therapy
Full Information
NCT ID
NCT00545974
First Posted
October 16, 2007
Last Updated
October 26, 2020
Sponsor
University of California, San Francisco
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00545974
Brief Title
Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
Official Title
A Prospective, Randomized, Multi-Center, Double-Blind, 26 Week, Placebo-Controlled Trial of Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporal dementia.
The secondary objective of the study is to assess the safety and tolerability of long-term treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia.
The tertiary objective of the study is to determine whether treatment with memantine affects changes in weight
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled trial of memantine 10 mg twice daily versus placebo, at a ratio of 1:1, to receive active drug or placebo. Screening and enrollment is planned to last approximately one year. A Data and Safety Monitoring Board, consisting of a clinical pharmacist and 3 neurologists will review all AE reports approximately every 3 months after study initiation. The DSMB will notify the principal investigator, the study sponsor and the CHR if significant concerns are raised by their review of the AE data. An interim analysis of efficacy data will be conducted after 50% of the targeted enrollment population has completed 26 weeks of drug treatment.
Including screening and off-drug follow up, each subject will participate in the study for approximately 34 weeks.
The entire study is anticipated to last 86 weeks if enrollment is completed within one year of study initiation.
The targeted enrollment is 140.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontal Lobe Dementia, Frontotemporal Lobe Dementia, Semantic Dementia
Keywords
Randomized, Double-Blind, Placebo-Controlled, memantine, Namenda, Frontotemporal Dementia, Semantic Dementia, FTD, SD, dementia, behavioral decline, cognitive decline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Memantine 10mg BID
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo condition
Intervention Type
Drug
Intervention Name(s)
memantine
Intervention Description
memantine 10mg BID
Intervention Type
Drug
Intervention Name(s)
Placebo pill
Intervention Description
Placebo pill BID
Primary Outcome Measure Information:
Title
Change in Neuropsychiatric Inventory (NPI)
Description
NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions indicate that the patient has problems with a particular sub-domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequency of the symptoms on a 4-point scale, their severity on a 3-point scale, and the distress the symptom causes them on a 5-point scale. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.
Time Frame
Baseline, 26 weeks
Title
Clinical Global Impression of Change (CGIC)
Description
The scale is rated on a 7-point scale, using a range of responses from 1 (very much improved) through 7 (very much worse). The clinician compares the participant's current condition to the condition at admission to the project.
Time Frame
26 Weeks
Secondary Outcome Measure Information:
Title
Longitudinal Changes From Baseline to 26 Weeks for Test Battery: CDR-SB, FAQ, TFLS, MMSE, EXIT25, UPDRS, Boston Naming Test
Description
Clinical dementia rating sum of boxes CDR-SB (0-18) high scores indicate high impairment.
Functional activities questionnaire FAQ (0-30) high scores indicate high impairment.
Texas functional living scale TFLS (0 to 52) high scores suggest better instrumental activities of daily living functioning.
Mini-Mental State Examination MMSE (0-30) low scores indicate low cognition. The executive interview EXIT25 (0 to 50) high scores indicate more executive impairment.
A modified unified Parkinson's disease rating scale UPDRS (0-199) high scores indicate worse disability.
Boston naming test (0-15) low scores indicate more retrieval difficulties.
Time Frame
Baseline and 26 Weeks
Title
Longitudinal Changes From Baseline to 26 Weeks for Test Battery: Letter Fluency, Category Fluency, Digit Symbol, Digits Backwards
Description
Letter fluency, score is number of words recalled starting with a specified letter for 60 seconds. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials for the score. Low scores indicate high impairment
Category fluency, score is number of items generated belonging to a specific category (such as animals) in 60 seconds, low scores indicate high impairment.
Digit symbol, score is number of symbols that correctly corresponded to the random numerals entered in the form in 90 seconds. Participants are given a table of numerals with matching symbols, and a form with random numerals with open spaces. Low scores indicate high impairment.
Digits backwards, score is number of digits backwards recalled (range: 0-14), The participant hears a list of digits and is asked to repeat the digits backwards. Low scores indicate high impairment.
Time Frame
Baseline and 26 Weeks
Title
Number of Participants Starting Antipsychotic Therapy
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A subject must meet ALL of the following criteria to be considered for enrollment in this study:
Signed and dated written informed consent obtained from the subject and the subject's caregiver in accordance with local IRB regulations.
Must meet criteria Neary et al. criteria for frontotemporal dementia (FTD) or semantic dementia (SD)
Age: 40-80
CT or MRI of brain within 12 months consistent with a diagnosis of FTD or SD.
MMSE ≥ 15 at screening visit.
Judged by investigator to be able to comply with neuropsychological evaluation at baseline.
Must have reliable caregiver accompany subject to all study visits. Caregiver must read, understand and speak English fluently in order to ensure comprehension of informed consent form and informant-based assessments of subject. Caregiver must also have frequent contact with subject (at least 3 times per week for one hour) and be willing to monitor study medication compliance and the subject's health and concomitant medications throughout the study.
In the opinion of the investigator, the patient and the caregiver will be compliant with the protocol and have a high probability of completing the study.
Exclusion Criteria:
Any one of the following will exclude a subject from being enrolled into the study:
Insufficient fluency in English to complete neuropsychological and functional assessments.
Concurrent Motor Neuron Disease judged by investigator to have bulbar or upper extremity impairments at baseline that would interfere with neuropsychological assessment, or that are expected to lead to such impairments within one month.
Exclusion criteria as listed in Neary criteria. Diagnosis of progressive nonfluent aphasia by Neary criteria.
Use of memantine within 4 weeks prior to randomization.
Evidence of other neurological or psychiatric disorders which preclude diagnosis of FTD (including, but not limited to, stroke, Parkinson's disease, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, or head injury with loss of consciousness) within the past year.
Concurrent treatment with acetylcholinesterase inhibitors, antipsychotic agents, mood stabilizers (valproate or lithium) or benzodiazepines (other than temazepam or zolpidem), or use of any of these agents within 4 weeks prior to randomization. Atypical antipsychotic agents may be started after the baseline visit if felt to be medically necessary by the investigator and will be recorded as a secondary outcome measure.
History of alcohol or substance abuse within 1 year prior to screening, if deemed clinically significant by investigator.
Any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
Clinically significant lab abnormalities at screening, including Creatinine ≥ 1.7, B12 below laboratory normal reference range or TSH above site's laboratory normal reference range. Subjects with abnormal B12 or TSH levels at screening may be included per investigator's discretion.
9. CT or MRI evidence of any of the following: hydrocephalus, stroke, space-occupying lesion, cerebral infection or any clinically significant CNS disease other than FTD.
10.Systolic blood pressure greater than 180 or less than 90 mm Hg. Diastolic blood pressure greater than 105 or less than 50 mm Hg.
11. Abnormal ECG at screening judged to be clinically significant by the investigator.
12. Use of investigational drugs or participation in investigational drug study within 60 days of screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam L. Boxer, M.D., Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Miller, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-1207
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7025
Country
United States
Facility Name
University Hospitals of Cleveland / Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44120
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
12. IPD Sharing Statement
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Links:
URL
http://memory.ucsf.edu/
Description
UCSF Memory and Aging Center
Learn more about this trial
Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
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