Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia

NCT00294554 | Completed Results

• 1 other identifier: 04-08-20-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to evaluate the usefulness of memantine, compared to placebo (sugar pill), for the treatment of cognitive impairment in patients with idiopathic Parkinson's disease (PD) and dementia. Memantine is used as a safe and effective treatment for patients with Alzheimer's disease. Cognitive impairment includes concentration and memory difficulties. We will look at how well this medication helps your cognitive impairment, how well you tolerate this medication (including its effects on your motor symptoms of PD) your activities of daily living, your emotions, and any medical conditions you might have. We will interview a person you choose as your "informant".

Conditions

Parkinson's Disease; Cognitive Impairment; Dementia

Keywords

Parkinson's Disease; Cognitive Impairment; Dementia; Memory

Outcome Measures

Primary Outcomes (2)

• Change in Dementia Rating Scale (DRS) Memory Subscore

  The DRS is comprised of: Attention (ATT, 8 items); Initiation-Perseveration (I-P, 11 items); Construction (CONST, 6 items); Conceptualization (CONCEPT, 6 items); and Memory (MEM, 5 items). For this study, only the memory subscore was used, with score possibilities ranging from 0-5, with 5 meaning memory was perfect, 0 being no ability to recall. A negative score indicates a decrease in memory from baseline to 24 weeks.

  change from baseline to 24 weeks

• CIBIC-Plus Score

  CIBIC-Plus is based upon clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. It takes into account a subject's overall function in the cognitive, behavioral and functional activity domains. Scoring is based on an interview with the caregiver and examination of the patient by an independent evaluator, without consulting other information such as cognitive test results. It requires the assessor to consider a number of cognitive, functional, and behavioral areas prior to providing an overall "global" assessment of clinical change. 7-point categorical scale that provides a single global rating of change from baseline.A score of 1 indicates marked improvement;and a score of 7, marked worsening.

  24 weeks

Study Arms (2)

Active Memantine

ACTIVE COMPARATOR

Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.

Drug: Memantine

Placebo Oral Tablet

PLACEBO COMPARATOR

Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.

Drug: Placebo Oral Tablet

Interventions

Memantine DRUG

Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed.

Also known as: Namenda

Active Memantine

Placebo Oral Tablet DRUG

Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed.

Also known as: Placebo

Placebo Oral Tablet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic PD, as defined by UK Brain Bank Criteria.
• Age onset of PD \> 35 years old
• Adult men and women, current age \> 50 years
• English speaking
• Any race or ethnic background.
• Hoehn and Yahr Stage I-V, provided able to participate verbally in clinical assessments and travel to clinic.
• Diagnosis of dementia secondary to PD, as defined by DSM-IV-TR.
• Stable medical health
• Taking stable doses for 2 months of non-excluded medications.
• Outpatient status (may be residing in a long-term care facility).
• Able to attend all study visits with an informed caregiver/partner who is willing to provide information on the patient's clinical status and response to treatment.
• Presence of an informed caregiver willing to take part in weekly phone call follow-up calls for the duration of study enrollment.
• Provision of informed consent by patient and caregiver and/or legal guardian.
• On stable antiparkinsonian therapy for 2 months.
• If history of major depression or anxiety disorder, must have stable symptoms and be on stable therapy for 2 months.

You may not qualify if:

• History or evidence of neurodegenerative disorder other than PD.
• Meets clinical criteria for Dementia with Lewy Bodies.
• History or current evidence of epilepsy.
• Participation in another investigational drug trial within 2 months of screening.
• Treatment with memantine within 60 days of screening.
• Current symptomatic Major Depressive Disorder, as based on Hamilton Depression Rating Scale Score \> 17.
• Current clinically significant hepatic, kidney disease, gastrointestinal, endocrine, or cardiovascular disease, including evidence of second or third degree heart block. \[Note, patients with controlled hypertension (supine diastolic BP\<95 mm Hg), complete or partial right bundle branch block, pacemakers, or deep brain stimulators may be included.\].

Sponsors & Collaborators

• Johns Hopkins University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction; Dementia

Interventions

Memantine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Laura Marsh, MD
• Organization: Johns Hopkins University School of Medicine

laura.marsh2@va.gov

713-794-8907

Study Officials

• Laura Marsh, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 22, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 12, 2017
• Results First Posted: September 12, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)