<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02988908</url>
  </required_header>
  <id_info>
    <org_study_id>SU-06302009-2820</org_study_id>
    <secondary_id>R01MH035182</secondary_id>
    <secondary_id>eprotocol #7530</secondary_id>
    <nct_id>NCT02988908</nct_id>
  </id_info>
  <brief_title>Memory and Mental Health in Aging</brief_title>
  <official_title>Memory and Mental Health in Aging: Psychopharmacological Augmentation of Memory Training in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A comparison of memory training with and without donepezil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study 1:&#xD;
&#xD;
      Investigators evaluated the short-term and longer-term efficacy and effectiveness of a&#xD;
      pharmacologic augmentation strategy for a nonpharmacologic treatment to improve memory&#xD;
      performance in nondemented older adults. Investigators used a randomized controlled trial&#xD;
      with parallel groups design that compares two Treatments: DONEPEZIL + COGNITIVE TRAINING&#xD;
      versus PLACEBO + COGNITIVE TRAINING.&#xD;
&#xD;
      Study 2:&#xD;
&#xD;
      The second study looked more closely at dosage. Investigators hoped to determine the best&#xD;
      dosage of the drug donepezil for enhancing the effects of the memory training program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2000</start_date>
  <completion_date type="Actual">September 2007</completion_date>
  <primary_completion_date type="Actual">September 2007</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in recall of Word List over time</measure>
    <time_frame>measured at baseline, Week 13 (before training), Week 14 (at end of training), and Week 52</time_frame>
    <description>Each participant was given a list of 16 words. Participants had 4 minutes to memorize the words in order. Short-term recall was tested after 5 minutes exposure to a distractor task and delayed recall was tested after 30 minutes. At recall participants were asked to recall as many words as they could remember in the order the words were presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in recall of Name-Face pairs over time</measure>
    <time_frame>measured at baseline, Week 13 (before training), Week 14 (at end of training), and Week 52</time_frame>
    <description>Each participant was shown 12 name-face pairs for 1 minute. Recall was tested immediately after presentation of all 12 name-face pairs (faces were shown for 1 minute and participant was asked to supply the name).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Symbol Digit score over time</measure>
    <time_frame>measured at baseline, Week 13, and Week 52</time_frame>
    <description>Symbol Digit modalities test (Smith 1991)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Digit Span score over time</measure>
    <time_frame>measured at baseline, Week 13, and Week 52</time_frame>
    <description>Digit Span from the Wechsler, 1987</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medical Outcomes Study Functioning and Well-being Profile over time</measure>
    <time_frame>measured at baseline, Week 13, and Week 52</time_frame>
    <description>Measuring Functioning and Well-Being is a comprehensive account of a broad range of self-reported functioning and well-being measures developed for the Medical Outcomes Study (Stewart AL, 1992)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Everyday Problems Test score over time</measure>
    <time_frame>measured at baseline, Week 13 (before training), and Week 52</time_frame>
    <description>Measure of Functional Capacity (Willis SL, Mariske M, 1993)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Memory</condition>
  <arm_group>
    <arm_group_label>Drug: Donepezil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received Donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.&#xD;
Participants also received 2 weeks of memory training at weeks 13-14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Control)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.&#xD;
Participants also received 2 weeks of memory training at weeks 13-14</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil</intervention_name>
    <description>Participants received donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.&#xD;
Participants also received 2 weeks of memory training at weeks 13-14</description>
    <arm_group_label>Drug: Donepezil</arm_group_label>
    <other_name>Aricept</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Participants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.&#xD;
Participants also received 2 weeks of memory training at weeks 13-14</description>
    <arm_group_label>Placebo (Control)</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Study 1 only:&#xD;
&#xD;
          1. Global Clinical Dementia Rating (CDR) 0.0 or 0.5, at least 1 Box score = 0.5 and none&#xD;
             &gt; 0.5;&#xD;
&#xD;
          2. Laboratory normal B12, RPR, and Thyroid Function Tests or without any clinically&#xD;
             significant abnormalities that would be expected to interfere with the study, plus&#xD;
             general clinical chemistry and complete blood count.&#xD;
&#xD;
          3. ECG without clinically significant abnormalities that would be expected to interfere&#xD;
             with the study&#xD;
&#xD;
        Study 1 and Study 2:&#xD;
&#xD;
          1. Mini-Mental Exam score between 24 and 30 (inclusive);&#xD;
&#xD;
          2. General cognition and functional performance sufficiently preserved such that a&#xD;
             diagnosis of Alzheimer's Disease cannot be made by the site physician at the time of&#xD;
             the screening visit;&#xD;
&#xD;
          3. Permitted medications stable for at least 1 month prior to screening. In particular:&#xD;
             a) Subjects may take stable doses of antidepressants lacking significant&#xD;
             anticholinergic side effects (if they are not currently depressed and do not have a&#xD;
             history of major depression within the past 2 years). b) Estrogen replacement therapy&#xD;
             is permissible. c) Ginkgo biloba is permissible, but discouraged.&#xD;
&#xD;
          4. Hamilton Depression Score less than or equal to 12 on the 17-item scale.&#xD;
&#xD;
          5. Visual and auditory acuity adequate to allow neuropsychological testing.&#xD;
&#xD;
          6. General health good with no additional diseases expected to interfere with the study.&#xD;
&#xD;
          7. Women two years post-menopausal or surgically sterile.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any significant neurologic disease such as Possible and Probable AD, Parkinson's&#xD;
             disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus,&#xD;
             brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma,&#xD;
             multiple sclerosis, or history of significant head trauma followed by persistent&#xD;
             neurologic defaults or known structural brain abnormalities.&#xD;
&#xD;
          2. Major depression or another major psychiatric disorder as described in DSM IV within&#xD;
             the past 2 years. History of schizophrenia (DSM IV criteria). Psychotic features,&#xD;
             agitation or behavioral problems within the last 3 months which could lead to&#xD;
             difficulty complying with the protocol.&#xD;
&#xD;
          3. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV&#xD;
             criteria).&#xD;
&#xD;
          4. Any significant systemic illness or unstable medical condition which could lead to&#xD;
             difficulty complying with the protocol including:&#xD;
&#xD;
               1. History of systemic cancer within the last 5 years (non-metastatic skin cancers&#xD;
                  are acceptable).&#xD;
&#xD;
               2. History of myocardial infarction within the past year or unstable or severe&#xD;
                  cardiovascular disease including angina or CHF with symptoms at rest.&#xD;
&#xD;
               3. Clinically significant obstructive pulmonary disease or asthma.&#xD;
&#xD;
               4. Clinically significant and unstable gastrointestinal disorder such as ulcer&#xD;
                  disease or a history of active or occult gastrointestinal bleeding within two&#xD;
                  years.&#xD;
&#xD;
               5. Insulin-requiring diabetes or uncontrolled diabetes mellitus.&#xD;
&#xD;
               6. Uncontrolled hypertension (systolic BP greater than 170 or diastolic greater than&#xD;
                  100).&#xD;
&#xD;
               7. History of clinically significant liver disease, coagulopathy, or vitamin K&#xD;
                  deficiency within the past 2 years.&#xD;
&#xD;
          5. Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4&#xD;
             weeks prior to screening. b) Use of anti-Parkinsonian medications (e.g. Sinemet,&#xD;
             amantadine, bromocriptine, pergolide and selegiline) within 2 months prior to&#xD;
             screening. c) Use of neuroleptics or narcotic analgesics within 4 weeks prior to&#xD;
             screening. d) Use of long-acting benzodiazepines or barbiturates within 4 weeks prior&#xD;
             to screening. e) Use of short-acting anxiolytics or sedative hypnotics more frequently&#xD;
             than 2 times per week within 4 weeks prior to screening (note: sedative agents should&#xD;
             not be used within 72 hours of screening). f) Initiation or change in dose of an&#xD;
             antidepressant lacking significant cholinergic side effects within the 4 weeks prior&#xD;
             to screening (use of stable doses of antidepressants for at least 4 weeks prior to&#xD;
             screening is acceptable). g) Use of systemic corticosteroids within 3 months prior to&#xD;
             screening. h) Medications with significant cholinergic or anticholinergic side effects&#xD;
             (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4&#xD;
             weeks prior to screening. i) Use of anti-convulsants (e.g. Phenytoin, Phenobarbital,&#xD;
             Carbamazepine) within 2 months prior to screening. j) Use of warfarin (Coumadin)&#xD;
             within 4 weeks prior to screening.&#xD;
&#xD;
          6. Any prior use of any FDA approved medications for the treatment of Alzheimer's Disease&#xD;
             (e.g. tacrine, donepezil, or other newly approved medications).&#xD;
&#xD;
          7. Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer,&#xD;
             prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jerome A Yesavage</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>May 11, 2010</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>February 9, 2017</last_update_submitted>
  <last_update_submitted_qc>February 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Jerome A Yesavage,</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Donepezil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02988908
org study id: SU-06302009-2820
secondary id: R01MH035182
secondary id: eprotocol #7530
nct id: NCT02988908
lead sponsor: 
collaborator: 
has dmc: No
A comparison of memory training with and without donepezil.
Study 1:

      Investigators evaluated the short-term and longer-term efficacy and effectiveness of a
      pharmacologic augmentation strategy for a nonpharmacologic treatment to improve memory
      performance in nondemented older adults. Investigators used a randomized controlled trial
      with parallel groups design that compares two Treatments: DONEPEZIL + COGNITIVE TRAINING
      versus PLACEBO + COGNITIVE TRAINING.

      Study 2:

      The second study looked more closely at dosage. Investigators hoped to determine the best
      dosage of the drug donepezil for enhancing the effects of the memory training program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in recall of Word List over time
time frame: measured at baseline, Week 13 (before training), Week 14 (at end of training), and Week 52
description: Each participant was given a list of 16 words. Participants had 4 minutes to memorize the words in order. Short-term recall was tested after 5 minutes exposure to a distractor task and delayed recall was tested after 30 minutes. At recall participants were asked to recall as many words as they could remember in the order the words were presented.
measure: Change in recall of Name-Face pairs over time
time frame: measured at baseline, Week 13 (before training), Week 14 (at end of training), and Week 52
description: Each participant was shown 12 name-face pairs for 1 minute. Recall was tested immediately after presentation of all 12 name-face pairs (faces were shown for 1 minute and participant was asked to supply the name).
measure: Change in Symbol Digit score over time
time frame: measured at baseline, Week 13, and Week 52
description: Symbol Digit modalities test (Smith 1991)
measure: Change in Digit Span score over time
time frame: measured at baseline, Week 13, and Week 52
description: Digit Span from the Wechsler, 1987
measure: Change in Medical Outcomes Study Functioning and Well-being Profile over time
time frame: measured at baseline, Week 13, and Week 52
description: Measuring Functioning and Well-Being is a comprehensive account of a broad range of self-reported functioning and well-being measures developed for the Medical Outcomes Study (Stewart AL, 1992)
measure: Change in Everyday Problems Test score over time
time frame: measured at baseline, Week 13 (before training), and Week 52
description: Measure of Functional Capacity (Willis SL, Mariske M, 1993)
arm group label: Drug: Donepezil
arm group type: Experimental
description: Participants received Donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14
arm group label: Placebo (Control)
arm group type: Placebo Comparator
description: Participants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14
intervention type: Drug
intervention name: Donepezil
description: Participants received donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14
arm group label: Drug: Donepezil
other name: Aricept
intervention type: Drug
intervention name: Placebos
description: Participants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14
arm group label: Placebo (Control)
other name: Control
criteria: 
gender: All
minimum age: 55 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jerome A Yesavage
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Jerome A Yesavage,
investigator title: Principle Investigator
mesh term: Donepezil
sharing ipd: No