American Psychiatric Association Council on Aging

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American Psychiatric AssociationCouncil on Aging

• Neuropharmacological Drug Products
• Psychophamacological Drugs Advisory Committee
• Psychiatric and Behavioral Disturbances
  Associated with Dementia
• Food and Drug Administration
• March 9, 2000

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American Psychiatric Association

• Presenters
• Christopher C. Colenda, MD, MPH
• Chair Council on Aging
• Jacobo Mintzer, MD
• Chair Committee on Ethnic Minority Elderly

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Behavioral and Psychological Symptoms of Dementia

• The above term does not define a specific
  clinical entity for purposes of drug development
• The central question for the committee is whether
  there is sufficient scientific evidence that
  specific psychiatric symptoms are fundamental
  manifestations of the Alzheimers disease, and
  thus warrant drug development or indication

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Conceptual Model of Disease
Latency
Induction
Promotion
Expression
Initiation of Pathological Process
Clinical Detection of the Disease (Onset of Signs
and Symptoms)
Initiation of the Etiological Process
Outcome of the Disease
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Criteria Used to Assess Available Evidence
Supporting a Causal Interpretation
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Circadian-Rhythm Disturbances(Sleep-Wake
Disturbances)
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Psychosis Due to DAT
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Benefits of Establishing Appropriate Targets for
Pharmacological intervention

• Psychoactive drugs are widely used in DAT
• Off label use expose patients to severe side
  effects without evidence of possible benefit
• Labeling will provide information on therapeutic
  targets and safety information specific to the
  targeted population

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Benefits of Establishing Appropriate Targets for
Pharmacological intervention

• The establishment of specific labeling will
  provide with a strong incentive for the
  development of safer and more effective compounds
  to treat these difficult psychiatric syndromes

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Conclusion

• Psychiatric syndromes are part of the core
  manifestation of DAT
• There is enough scientific evidence to support
  the labeling for psychosis, alteration in
  circadian rhythm and depression as valid targets
  for pharmacological intervention in DAT
• Other psychiatric syndromes should be considered
  as scientific evidence becomes available