Treatment Study of Frontotemporal Dementia

Plain-language summary

This study investigates treatment of Frontotemporal Dementia (FTD). It included patients aged 45-95 with mild-to-moderate FTD who met specific diagnostic criteria. It is a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Start date

7/23/2004

Estimated completion

6/1/2009

Countries

United States

Related genes

Locations

• Bethesda, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

* INCLUSION CRITERIA:

  1. FTD as diagnosed by the Lund-Manchester criteria including patients with diagnoses of Semantic Dementia or Primary Progressive Aphasia.
  2. Ages 45 to 95 years old.
  3. Mild-to-moderate (CDR 1 to 2) FTD with an assigned durable power of attorney.

EXCLUSION CRITERIA:

1. Diagnosis of any form of dementia besides FTD, including AD, Lewy body dementia, vascular dementia, dementia associated with Parkinson's disease, Corticobasal Degeneration and Progressive Supranuclear Palsy.
2. Severe dementia (CDR 3).
3. Known allergy or serious adverse reaction to quetiapine or dextroamphetamine.
4. Patient is already receiving a stimulant (methylphenidate, dextroamphetamine, pemoline, or modafinil), or an antipsychotic medication, typical or atypical, including prochlorperazine and metoclopromide.
5. Patients taking any of the following medications because of their potential interaction with dextroamphetamine: MAO use currently or within 14 days prior to start of study, Furazolidone, Guanethidine, norepinephrine, sibutramine, tricyclic antidepressants, carbonic anhydrase inhibitors.
6. Patients taking the following medications because of their potential interaction with quetiapine: Carbamazepine, clozapine, lithium, thioridazine.
7. History of CVA, or at significantly increased risk for CVA (e.g., atrial fibrillation, recent TIA etc.).
8. Symptomatic cardiovascular disease (i.e., angina, claudication, TIAs, syncope), uncontrolled hyper or hypotension, or a tic disorder.
9. Any medical contraindication to performing the procedures involved in the study including blood draws or lumbar puncture.
10. We will require a woman of child-bearing age to have a pregnancy test prior to starting the study medications and to use contraception during the course of the study.
11. Patients with a previous negative trial of a stimulant.
12. Patients with a history of severe psychosis.
13. Patients with a history of recent substance abuse.
14. Patients with QTc prolongation on a baseline EKG.
15. A score of 2 or less on the Communication Functional Ratings - Swallowing Domain.