Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.
Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.
Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease.
The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
調査の概要
詳細な説明
Study design :
Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France
Population :
50 drug-naïve patients with Parkinson's disease, with apathy. 2 groups : 25 patients with placebo and 25 patients with rasagiline.
3 visits
- Visit 1 : inclusion / randomisation/ first study medication dispensation
- Visit 2 (1.5 month after V1) : first evaluation and second study medication dispensation.
- Visit 3 (3 months after V1, final visit) : second evaluation
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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Clermont-Ferrand、フランス、63003
- CHU Clermont-Ferrand
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Drug-naïve patients with Parkinson's disease (UKPDBB criteria)
- No dementia (Mattis dementia rating scale > 130; Mini Mental Sate Examination ≥26)
- No depression (MADRS < 15)
- Criteria of apathy from Robert et al (2009)
- At least mild apathy (≥-21 to Lille Apathy Rating Scale)
- Age : 35-70 y
- Affiliation to social security
- Agreement of patients
Exclusion Criteria:
- - Any antiparkinsonian treatment (L.dopa, dopamine agonists, MAO-B-I, amantadine, anticholinergics). Patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.
- Ongoing severe psychiatric or somatic diseases
- Others treatments :
- antipsychotics
- antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)
- psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin C, sulbutiamine, glutamic acid, aspartic acid)
- any contra-indication according to SmPC
- patients under guardianship
- Women without efficient contraception
- Person who participate to an other study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：rasagiline
Randomized, double-blind, rasagiline (1 mg) vs placebo study.
Parallel group (randomization 1/1).
Duration 3 months 16 recruiting centers in France
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プラセボコンパレーター：placebo
Randomized, double-blind, rasagiline (1 mg) vs placebo study.
Parallel group (randomization 1/1).
Duration 3 months 16 recruiting centers in France
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Lille Apathy Rating Scale (LARS) score
時間枠：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Motor assessment : Unified Parkinson's Disease Rating Scale
時間枠：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale
時間枠：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Self assessment of apathy : Starkstein
時間枠：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Quality of life : PDQ 39
時間枠：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery
時間枠：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Hyperdopaminergic symptoms : Parkinson's disease behavioral scale
時間枠：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Fatigue assessment : Parkinson Fatigue Scale
時間枠：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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協力者と研究者
協力者
捜査官
- 主任研究者：Denis PEZET、University Hospital, Clermont-Ferrand
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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