Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study

NCT00495820 | Completed Phase 4 Results DMC

• 1 other identifier: MHBB-011-06F
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the efficacy of methylphenidate over placebo in treating apathy in patients with Alzheimer's dementia. Apathy is one of the earliest and most profound disturbances that occur in Alzheimer's dementia (AD). Hypotheses: 1. Methylphenidate (MPH) will improve apathy significantly more than placebo in AD. 2\. Successful treatment of apathy will improve Instrumental Activities of Daily Living (IADLs), and caregiver burden.

Conditions

Alzheimer's Disease; Apathy; Dementia

Keywords

Alzheimer's Disease; Apathy; Dementia; Methylphenidate

Outcome Measures

Primary Outcomes (1)

• Apathy Evaluation Scale Score at 12 Weeks

  The Apathy Evaluation Scale (AES) has been specifically developed to assess apathy and discriminate it from depression. This 18 item scale with score ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. Higher scores indicate worsening apathy.

  At 12 weeks

Secondary Outcomes (2)

• Mini-mental State Examination (MMSE) at 12 Weeks

  At 12 weeks

• Clinical Global Impression

  At 12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Methylphenidate

Drug: Methylphenidate

Arm 2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Methylphenidate DRUG

Subject will receive 5mg twice a day for two weeks then 10mg twice a day until week 12 of the study.

Also known as: Ritalin

Arm 1

Placebo OTHER

Standard inactive pill.

Arm 2

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of dementia of the Alzheimer type (DSM-IV Text Revision (TR) criteria)
• Mini-mental state examination (MMSE) \>18, but \<29
• Apathy Evaluation Scale (AES) score of more than 40
• Ability to provide informed consent by either the patient or caregiver.
• If subjects are being treated with antidepressants, they should be on a stable dose of antidepressants for at least two months prior to the enrollment into the study.
• If subjects are being treated with cholinesterase inhibitors and memantine, they should be on stable dose of those medications at least four months prior to the enrollment into the study.

You may not qualify if:

• Patient currently taking methylphenidate or hypersensitivity or prior significant adverse events with methylphenidate.
• Patients currently taking Adderall (amphetamine mixed salts) or Dexedrine (dextroamphetamine sulphate) or any other amphetamine product.
• Uncontrolled hypertension (BP \> 140/90) or tachycardia (100) at screening visit
• Patients with frontotemporal dementia
• Patients meeting criteria for Major Depressive Disorder on the Mini International Neuropsychiatric Inventory (MINI)
• Patients with active psychosis as determined by MINI
• Patients currently being treated with antipsychotics
• History of uncontrolled seizure disorder
• History of malignant hypertension, symptomatic cardiovascular disease, cardiomyopathy, known structural cardiac defect or medically unstable arrhythmias.
• History of Tourette's syndrome or presence of motor tics
• Patients with glaucoma
• Patients taking monoamine oxidase inhibitors (MAOIs)
• Patient taking clonidine

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Medical Center, Omaha

Omaha, Nebraska, 68105-1873, United States

Location

Related Publications (2)

• Padala PR, Burke WJ, Shostrom VK, Bhatia SC, Wengel SP, Potter JF, Petty F. Methylphenidate for apathy and functional status in dementia of the Alzheimer type. Am J Geriatr Psychiatry. 2010 Apr;18(4):371-4. doi: 10.1097/JGP.0b013e3181cabcf6.

  PMID: 20220576 RESULT

• Padala PR, Padala KP, Lensing SY, Ramirez D, Monga V, Bopp MM, Roberson PK, Dennis RA, Petty F, Sullivan DH, Burke WJ. Methylphenidate for Apathy in Community-Dwelling Older Veterans With Mild Alzheimer's Disease: A Double-Blind, Randomized, Placebo-Controlled Trial. Am J Psychiatry. 2018 Feb 1;175(2):159-168. doi: 10.1176/appi.ajp.2017.17030316. Epub 2017 Sep 15.

  PMID: 28945120 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Lethargy; Dementia

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Small sample size and short duration of the study are two important limitations of the study. All male subjects in the study also make it difficult to generalize the results.

Results Point of Contact

• Title: Prasad Padala, MD, MS, Associate Director for Clinical Programs, GRECC
• Organization: Central Arkansas Veterans Healthcare System

prasad.padala@va.gov

5012572537

Study Officials

• Prasad R. Padala

  VA Medical Center, Omaha

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 3, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 20, 2015
• Results First Posted: November 20, 2015

Record last verified: 2015-10

Locations

US (1)